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Sources: EU EUDAMED, US FDA
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HL60145538
Certificate
IVDD Annex IV (excluding sections 4, 6)·GB Lifecare Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs
5-867-600-1907
Certificate
MDD Annex VI·MDE Kft.·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·1 Basic UDI-DI
QPZ-01910-18
Certificate
MDD Annex V·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
QCT-0176-21
Certificate
MDD Annex II (excluding section 4)·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
2116232DE01
Certificate
MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·3 Basic UDI-DIs
2116232DE02
Certificate
MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·2 Basic UDI-DIs
37814
Certificate
MDD Annex II (excluding section 4)·Resilience MD·GMED SAS·1 Basic UDI-DI
2174771CE01
Certificate
MDD Annex II (excluding section 4)·Merlin MD Pte. Ltd.·DEKRA Certification B.V.·20 Basic UDI-DIs
2174771DE01
Certificate
MDD Annex II Section 4·Merlin MD Pte. Ltd.·DEKRA Certification B.V.·18 Basic UDI-DIs
2174771CE1
Certificate
MDD Annex II (excluding section 4)·Merlin MD Pte. Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI
2174771DE02
Certificate
MDD Annex II Section 4·Merlin MD Pte. Ltd.·DEKRA Certification B.V.·3 Basic UDI-DIs
DZ 2343368-1
Certificate
MDR QA·Jiangsu HXRT MD Co.,Ltd·TÜV Rheinland LGA Products GmbH
CE 671277
Certificate
MDD Annex II Section 4·United Orthopedic Corporation·BSI Group The Netherlands B.V.·161 Basic UDI-DIs
CE 671278
Certificate
MDD Annex II Section 4·United Orthopedic Corporation·BSI Group The Netherlands B.V.·61 Basic UDI-DIs
HD 2139743-1
Certificate
MDD Annex II (excluding section 4)·Unimax Medical Systems Inc.·TÜV Rheinland LGA Products GmbH·20 Basic UDI-DIs
CE 671275
Certificate
MDD Annex II Section 4·United Orthopedic Corporation·BSI Group The Netherlands B.V.·196 Basic UDI-DIs
2195-MED-2107701
Certificate
MDD Annex II Section 4·United Orthopedic Corporation·Szutest Uygunluk Değerlendirme A.Ş.·77 Basic UDI-DIs
CE 693526
Certificate
MDD Annex II Section 4·United Orthopedic Corporation·BSI Group The Netherlands B.V.·112 Basic UDI-DIs
CE 671280
Certificate
MDD Annex II Section 4·United Orthopedic Corporation·BSI Group The Netherlands B.V.·172 Basic UDI-DIs
CE 671281
Certificate
MDD Annex II Section 4·United Orthopedic Corporation·BSI Group The Netherlands B.V.·27 Basic UDI-DIs