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Notified Body Confirmation Letters for MDD Clients

European Regulation 2023/607, published in March 2023, extends MDD validity by up to five years. SGS Belgium NV, a Notified Body (NB 1639) designated against European Regulation 2017/745 (MDR), issues a Notified Body Confirmation Letter to an exisiting SGS MDD client when a formal transition application is received and a written agreement is signed.

Here you can browse the details of Notified Body Confirmation Letters, issued by SGS, for verification.

Notified Body Confirmation Letters issued by SGS

Organization name Reference numberValidity and extension date
AGU-PUNT, S.L.ES/BCN/300002729December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Air Liquide Medicinal, S.A.ES/MAD/231815December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Alma IT Systems, S.L.

ES/BCN/300004364

December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Amity Group Trading as Amity Limited, Amity International and Amity Healthcare EU Limited.GB/PC/214941December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Amson Vaccines & Pharma Pvt. Ltd. (Autodisable Syringe Plant)PK/LHR/220725December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Andersen Caledonia LimitedGB/PC/08642December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
APELEM SASFR/MD/238233December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
APT Medical Inc.CN/CSX/11683DGGDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
APT Medical Inc.CN/CSX/15350December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Arabian Medical Products Manufacturing Co., (ENAYAH)PK/LHR/213493December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
ARMSTRONG MEDICAL LTDGB/PC/08349December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
BASTOS VIEGAS S.A.ES/MAD/300002696December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Beijing Eternal Medical Technology Co., Ltd.CN/BJS/8007December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Beijing Konted Medical Technology Co., LtdCN/BJS/258232December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Beijing Med-Zenith Medical Scientific Corporation LimitedCN/BJS/7511December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Bimini Health TechWW/MC/606849December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Body Clock Health Care Ltd. also trading as Babycare TENSGB/PC/09334December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
BPR Medical LtdGB/PC/228381December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Brightwake Limited also trading as Advancis Medical and Advancis SurgicalGB/PC/227286December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
CHEMVIRON CARBON LTDGB/PC/04064December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Choyang Medical Industry Ltd.KR/SEL/Y-PC/14373December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
CIMA Technology, Inc.WW/MD4/616354December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
CIMA Technology, Inc.WW/MD4/616554December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
CIVCO Medical Instruments Co., Inc. DBA CIVCO and CIVCO Medical SolutionsWW/MC/08460December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
C-K DENTAL IND.CO.,LTD.WW/PCI/211452December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
COHO Biomedical Technology Co., Ltd.TW/TPE/K604313December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
COUSIN BIOTECHFR/MD/06953December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
CREATE MEDIC CO., LTD.JP/YOK/9151December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Crystalvue Medical CorporationTW/TPE/603613December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Organization nameReference numberValidity and extension date
DAESUNG MAREF CO., LTD.KR/SEL/Y-PC/14403December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Danyang Rapid Aid Hot And Cold Therapy Products Co., Ltd.CN/SZH/8412MDDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Daysoft LimitedGB/PC/200910December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Dongkuk Techco Rubber Industries Sdn. Bhd.MY/KUL/MY00346December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
DONGMUN CO., LTD.KR/SEL/Y-PC/11276December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Dr.Japan Co., Ltd.JP/YOK/4913December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
EAKIN SURGICAL LIMITEDGB/PC/02665December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Echo Electricity Co., Ltd.JP/YOK/11251December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
EUROPLAZ TECHNOLOGIES LTDGB/PC/228827December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
eVent Medical LtdWW/MD4/201252December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Facet Technologies, LLCWW/MC/08073December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Famidoc Technology Co., Ltd.CN/DGG/13545December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Farcomake For Advanced Medical Industry EG/CAI/PI219250December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
FKG Dentaire SàrlCH/GE/3205844December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Organization nameReference numberValidity and extension date
G-Flex Europe SprlBE/AND/2/1285.QMDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Graham Medical Technologies, LLC dba GraMedicaWW/MC/214088December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Guangzhou Ajax Medical Equipment Co., Ltd.CN/CAN/14841MDDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Guangzhou Beaconn Medical Science Technology Co., Ltd.CN/CAN/16366December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Guangzhou Fengdan Medical Equipment Co., Ltd.CN/CAN/14864MDDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Guilin Yikeshi Medical Instrument Co., Ltd.CN/GGX/CAN15440December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
HLL LIFECARE LIMITEDIN/CHE/235592December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
HT Co., Ltd.KR/SEL/15401December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
HUBERT DE BACKER NVBE/AND/211542December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
IBERHOSPITEX, S.A.ES/BCN/c300002049December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Idoman TeorantaGB/PC/222996December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
IMPLANTS DIFFUSION INTERNATIONAL s.a.r.lFR/MD/217462December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Intensiv SACH/GE/3205732December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
INTEROJO INC.WW/PCI/202192December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Intersurgical Ltd GB/PC/04303December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
JIANERKANG MEDICAL CO., LTD.CN/NGB/271496December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Jiangsu JEVKEV MedTec Co., Ltd.CN/BJS/266792December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Kora Corporation Limited trading as Kora HealthcareGB/PC/224976December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
KURARAY NORITAKE DENTAL INC.JP/YOK/4321December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Organization nameReference numberValidity and extension date
LABORATOIRE HUCKERT'S INTERNATIONAL SRLBE/AND/200467December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
LOWTEM CO., LTD.KR/SEL/Y-PC/11269December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
LSO MEDICAL SASFR/MD/237726December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
M.A.Arain & Brothers Pvt. Ltd also trading as MEDISANA INTERNATIONALPK/LHR/211230December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Makevale LtdGB/PC/201207December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Malvern Medical Developments Ltd also trading as PB Medical LimitedGB/PC/08783December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MCAREKOREA CO.LTD.KR/SEL/Y-PC/13349December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MDJ sasFR/MD/209213December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MDJ sasFR/MD/237804December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MED.E.COM s.a.r.l. trading as MEDECOMFR/MD/217815December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Medasil Surgical LtdGB/PC/240818December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Mediflex, a division of Flexbar Machine CorporationWW/MC/212209December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Meditech Kft.HU/BUD/20147218December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MEGA MEDICAL CO., LTD.WW/PCI/201067December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Mespere LifeSciences Inc.CN/SZX/14039December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
METROVISIONBE/AND/4/1211.QMDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Mi Gwang Contact Lens Co., Ltd.WW/PCI/200318December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MicroBase Technology Corp.TW/TPE/K605694December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MICRO-NX CO., LTD. KR/SEL/Y-PC/14366December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MIKASA X-RAY CO., LTD.JP/YOK/11856December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Minze NVBE/AMD/7/1040.QMDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
MOMINA KREPOST ADBG/SOF/200599December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
NANIWA RUBBER CO., LTD.JP/YOK/6148December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Nantong Health&Beyond Hygienic Products Inc.CN/SZH/7922MDDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
NIBEC Co., Ltd.KR/SEL/Y-PC/13355December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Ningbo Chinmed Technology Co., Ltd.CN/HGH/5478December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO.,LTD.CN/NGB/5879December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Novioscan B.V.BE/ANE/7/1177.QMDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Organization nameReference numberValidity and extension date
P3 Medical LimitedGB/PC/06145December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
PAN TAIWAN ENTERPRISE CO., LTD.TW/TPE/K603513December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Partners for Endoscopy LimitedGB/PC/240660December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Pfizer Manufacturing Belgium NVBE/AND/09715December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Pheasant Surgical CorporationPK/LHR/216808December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Planer LimitedGB/PC/240639December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Prima Medical LtdGB/PC/209781December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing LimitedGB/PC/207936December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Qisda Corporation also trading as Qisda Optronics (Suzhou) Co., Ltd.TW/TPE/607406December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Radialogica, LLCWW/MD4/605098December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
RADIOLOGÍA, S.A.ES/MAD/300003519
December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
RadioMed CorporationWW/MD4/209020December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Reliance Orthodontic Products, Inc.WW/MC/C617623December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
RENOSEM CO., LTD.KR/SEL/Y-PC/08201December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
RET, INC.KR/SEL/Y-PC/14394December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Rossmax International Ltd.TW/TPE/VW604603December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
RVC Medical IT B.V.BE/ANE/4/1229.QMDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Organization nameReference numberValidity and extension date
S.E. Carburos Metálicos, S.A. / Gasin II, Gases Industrias, Unipessoal, Lda ES/MAD/c300002046December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
SAUDI MAIS COMPANY FOR MEDICAL PRODUCTSPK/LHR/PK09228December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Serrix B.V.BE/AND/1/1236.QMDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Shenzhen Comen Medical Instruments Co., Ltd.CN/SZX/50010December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Shenzhen Hingmed Medical Instrument Co., Ltd.CN/SZX/50055December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
SHINA CorporationWW/PCI/150160December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Sinapi Biomedical (Pty) Ltd.ES/MAD/300003147December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
SLEEPINNOV TECHNOLOGYFR/MD/237723December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Sociedad Española de Electromedicina y Calidad, S.A. (SEDECAL)ES/MAD/c300002079December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
SOFARMABG/SOF/71223257December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Stafford Miller (Ireland) Ltd.GB/PC/225650December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
STARmed Co., Ltd.KR/SEL/Y-PC/09215December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Steroplast Healthcare LtdGB/PC/228394December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Stowood Scientific Instruments LtdGB/PC/209658December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
SUNGSHIM MEDICAL CO., LTDWW/PCI/201505December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
SURGICRAFTS also trading as NEAL MedicalPK/LHR/233024December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Suzhou Microclear Medical Instruments Co., LtdCN/SZH/8611MDDDecember 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
TAKASO RUBBER PRODUCTS SDN BHDMY/KUL/MY00109December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
TELEFIELD MEDICAL IMAGING LIMITEDCN/SZX/49926December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
TG Medical Sdn. Bhd.MY/KUL/MY00308December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Tianjin Walkman Biomaterial Co., Ltd.CN/TSN/8183December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
TOITU Co., Ltd.JP/YOK/5850December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
TOKAI MEDICAL PRODUCTS, INC.JP/YOK/8775December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Topdental (Products) LtdGB/PC/09563December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Tracey Technologies CorporationWW/MD4/600567December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Ultravision International LtdGB/PC/06796December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
UNISIS CORP.JP/YOK/8093December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
US X-RAY RÖNTGEN A.S.ES/MAD/300002893December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Organization nameReference numberValidity and extension date
Well-Life Healthcare LimitedTW/TPE/K602730December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
X-Tech Medical LimitedGB/PC/227110December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
YCELLBIO MEDICAL CO., LTDKR/SEL/Y-PC/12300December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
YUNG SHENG OPTICAL CO., LTD.TW/TPE/K604710December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition
Zhejiang Medtec Medical Devices Co., Ltd.CN/HGH/5417December 31, 2027 or December 31, 2028 depending on device classes & under surveillance condition

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