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Sources: EU EUDAMED, US FDA
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301001899
Certificate
MDD Annex II (excluding section 4)·SANDINE ZARTAUX HOLDING LTD·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY·1 Basic UDI-DI
23M00187CRT01
Certificate
MDR QMS·Dear Health Holding Company B.V.·Kiwa Dare B.V.
19M00166CRT04
Certificate
MDR QMS·Dear Health Holding Company B.V.·Kiwa Dare B.V.
SX 1701347-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Gold Standard Diagnostics Kassel GmbH·TÜV Rheinland LGA Products GmbH·555 Basic UDI-DIs
W01020202
Certificate
IVDD Annex IV (excluding sections 4, 6)·Gold Standard Diagnostics Kassel GmbH·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
Allergen Discs Senf
Certificate
IVDD Annex IV (excluding sections 4, 6)·Gold Standard Diagnostics Kassel GmbH·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
SX 1701347-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Gold Standard Diagnostics Kassel GmbH·TÜV Rheinland LGA Products GmbH·14 Basic UDI-DIs
1984-MDD-16-418
Certificate
MDD Annex II (excluding section 4)·GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ·Kiwa Belgelendirme Hizmetleri A.Ş.·391 Basic UDI-DIs
1984-MDD-16-417
Certificate
MDD Annex II (excluding section 4)·GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ·Kiwa Belgelendirme Hizmetleri A.Ş.·3011 Basic UDI-DIs
1984-MDD-19-623
Certificate
MDD Annex II Section 4·GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ·Kiwa Belgelendirme Hizmetleri A.Ş.·407 Basic UDI-DIs
GB19/964712
Certificate
MDD Annex II (excluding section 4)·Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited·SGS Belgium NV·380 Basic UDI-DIs
GB02/58222
Certificate
MDD Annex II (excluding section 4)·Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited·SGS Belgium NV·2 Basic UDI-DIs
gb19/964712
Certificate
MDD Annex II (excluding section 4)·Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited·SGS Belgium NV·1 Basic UDI-DI
GB19964712
Certificate
MDD Annex II (excluding section 4)·Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited·SGS Belgium NV·1 Basic UDI-DI
G1 103242 0002
Certificate
MDD Annex II (excluding section 4)·Suzhou ZOLL Medical Technology Co., Ltd.·TÜV SÜD Product Service GmbH·46 Basic UDI-DIs
ZOLL M2 Name: Defibrillator / Monitor
Certificate
MDD Annex II (excluding section 4)·Suzhou ZOLL Medical Technology Co., Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
G1 103242 0002
Certificate
MDD Annex II (excluding section 4)·Suzhou ZOLL Medical Technology Co., Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
252.1251
Certificate
MDD Annex II Section 4·Endologix LLC·National Standards Authority of Ireland (NSAI)·23 Basic UDI-DIs
252.1251
Certificate
MDD Annex II Section 4·Endologix LLC·National Standards Authority of Ireland (NSAI)·8 Basic UDI-DIs
37934
Certificate
MDD Annex II Section 4·Endologix LLC·GMED SAS·1 Basic UDI-DI