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IVDD Annex IV (excluding sections 4, 6)·OK biotech co., Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
M.2025.MDR.1062 - 1
Certificate
MDR Technical Documentation·DK Medical Technology Co., Ltd.·UDEM Adriatic d.o.o.·1 Basic UDI-DI
KR24/0000049
Certificate
MDR QMS·C-K DENTAL IND.CO.,LTD.·SGS Belgium NV
CE 621167
Certificate
MDD Annex II (excluding section 4)·Intact Vascular, Inc.·BSI Group The Netherlands B.V.·8 Basic UDI-DIs
CE 619984
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·712 Basic UDI-DIs
CE 673072
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·4 Basic UDI-DIs
CE 706141
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·98 Basic UDI-DIs
CE 649487
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·67 Basic UDI-DIs
CE 712825
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·47 Basic UDI-DIs
CE 649483
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·60 Basic UDI-DIs
CE 646778
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·24 Basic UDI-DIs
CE 619994
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·45 Basic UDI-DIs
E 649487
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical (Shenzhen) Co.,Ltd·BSI Group The Netherlands B.V.·1 Basic UDI-DI
1434-MDD-149/2021
Certificate
MDD Annex II Section 4·RFBio Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs
597638
Certificate
MDD Annex II Section 4·Allergan Sales, LLC·BSI Group The Netherlands B.V.·4 Basic UDI-DIs
EU-TDA-FI-20642-800030-2025-1
Certificate
IVDR Technical Documentation·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·Sertio Oy·1 Basic UDI-DI
EU-TDA-FI-06912-800035-2025-1
Certificate
IVDR Technical Documentation·Jiangsu Medomics Medical Technology Co.,Ltd.·Sertio Oy·1 Basic UDI-DI
FI17/07/007
Certificate
MDD Annex V·Monidor Oy·SGS FIMKO OY·1 Basic UDI-DI
FI17/07005
Certificate
MDD Annex II (excluding section 4)·Hetaida Technology Co., Ltd.·SGS FIMKO OY·2 Basic UDI-DIs
FI13/07001
Certificate
MDD Annex II (excluding section 4)·Optomed Oyj·SGS FIMKO OY·6 Basic UDI-DIs