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Sources: EU EUDAMED, US FDA
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FR20/81843524
Certificate
MDD Annex II (excluding section 4)·X-os S.A.·SGS Belgium NV·92 Basic UDI-DIs
FR20/81843524
Certificate
MDD Annex II (excluding section 4)·X-os S.A.·SGS Belgium NV·23 Basic UDI-DIs
BE24/000001249
Certificate
MDR QMS·CLOUDS OF CARE NV·SGS Belgium NV
HD 1015743-1
Certificate
MDD Annex II (excluding section 4)·W.O.M. World of Medicine GmbH·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
10000399607-PA-NA-HRV
Certificate
MDD Annex V·Croatian institute of transfusion medicine·DNV Product Assurance AS·40 Basic UDI-DIs
EPT 0477.MDD.20/4036
Certificate
MDD Annex II (excluding section 4)·Tree of Life Pharma Ltd.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI
EPT 0477.MDD.19/3135
Certificate
MDD Annex II (excluding section 4)·Tree of Life Pharma Ltd.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI
0425-MED-004425-00
Certificate
MDD Annex V·USP - UNION OF PHARMACEUTICAL SCIENCES S.r.l.·ICIM S.P.A.·2 Basic UDI-DIs
MDR-005
Certificate
MDR QMS·MESI, development of medical devices, Ltd.·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
MDR-006
Certificate
MDR QMS·Smart Blood Analytics Swiss SA·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
CR-03-1220-858-24
Certificate
MDR QMS·The wellbeing services county of Southwest Finland·Eurofins Electric & Electronics Finland Oy
41311197-02_Rev.2
Certificate
MDD Annex II (excluding section 4)·Invivo, a division of Philips Medical Systems·INTERTEK SEMKO AB·15 Basic UDI-DIs
G1 051640 0008
Certificate
MDD Annex II (excluding section 4)·Shantou Institute of Ultrasonic Instruments Co., Ltd.·TÜV SÜD Product Service GmbH·8 Basic UDI-DIs
CL 051640 0020
Certificate
MDD Annex II (excluding section 4)·Shantou Institute of Ultrasonic Instruments Co., Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
C-01-1220-769-21
Certificate
MDD Annex II (excluding section 4)·The wellbeing services county of Southwest Finland·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI
1434-IVDD-224/2022
Certificate
IVDD Annex III Section 6·Beijing North Institute of Biotechnology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs
5-859-200-1812
Certificate
MDD Annex II (excluding section 4)·Oculus Technologies of México S.A. de C.V.·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·79 Basic UDI-DIs
252.364
Certificate
MDD Annex V·Passy-Muir, Inc.·National Standards Authority of Ireland (NSAI)·6 Basic UDI-DIs
252.903
Certificate
MDD Annex II (excluding section 4)·Syncrophi Systems Ltd·National Standards Authority of Ireland (NSAI)·1 Basic UDI-DI
252.949
Certificate
MDD Annex II Section 4·Penumbra, Inc.·National Standards Authority of Ireland (NSAI)·1 Basic UDI-DI