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Sources: EU EUDAMED, US FDA
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84587CE01
Certificate
MDD Annex II (excluding section 4)·HTL-Strefa S.A.·TÜV Rheinland LGA Products GmbH·7 Basic UDI-DIs
G1 098579 0004
Certificate
MDD Annex II (excluding section 4)·Sol-Millennium Medical, Inc.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
G1 098579 0004
Certificate
MDD Annex II (excluding section 4)·Sol-Millennium Medical, Inc.·TÜV SÜD Product Service GmbH·23 Basic UDI-DIs
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
G1098579 0004
Certificate
MDD Annex II (excluding section 4)·Sol-Millennium Medical, Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
G1 098571 0004
Certificate
MDD Annex II (excluding section 4)·Sol-Millennium Medical, Inc.·TÜV SÜD Product Service GmbH·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.
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
HD 60135526
Certificate
MDD Annex II (excluding section 4)·Hangzhou Hua’an Medical & Health Instruments Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs
G1 067628 0031
Certificate
MDD Annex II (excluding section 4)·Zhejiang Haisheng Medical Device Co., Ltd.·TÜV SÜD Product Service GmbH·11 Basic UDI-DIs