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Sources: EU EUDAMED, US FDA
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5-909-204-2103
Certificate
MDD Annex II Section 4·BIOCERAMED - CERÂMICOS PARA APLICAÇÕES MÉDICAS, S.A.·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·1 Basic UDI-DI
44912221174
Certificate
MDR Technical Documentation·Rontis Corporation SA·TÜV NORD CERT GmbH
44912221174
Certificate
MDR Technical Documentation·Rontis Corporation SA·TÜV NORD CERT GmbH·2 Basic UDI-DIs
1434-MDD-166/2020
Certificate
MDD Annex II (excluding section 4)·Rontis Corporation SA·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·220 Basic UDI-DIs
1434-MDD-165/2020
Certificate
MDD Annex II Section 4·Rontis Corporation SA·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·216 Basic UDI-DIs
1434-MDD-166/2025
Certificate
MDD Annex II Section 4·Rontis Corporation SA·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs
1434-MDD-166/205
Certificate
MDD Annex II Section 4·Rontis Corporation SA·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
TNP/MDD/0389/51842021
Certificate
MDD Annex II (excluding section 4)·Rontis Corporation SA·TUV NORD Polska Sp. z o.o·1 Basic UDI-DI
TNP/MDD/0389/5184/2021
Certificate
MDD Annex II (excluding section 4)·Rontis Corporation SA·TUV NORD Polska Sp. z o.o·1 Basic UDI-DI
TNP/MDD/0389/5784/2021
Certificate
MDD Annex II (excluding section 4)·Rontis Corporation SA·TUV NORD Polska Sp. z o.o·1 Basic UDI-DI
2021-MDD/QS-052
Certificate
MDD Annex II (excluding section 4)·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·1 Basic UDI-DI
2021-MDD/DE-053
Certificate
MDD Annex II Section 4·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·1 Basic UDI-DI
2018-MDD/QS-032/C
Certificate
MDD Annex II (excluding section 4)·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·3 Basic UDI-DIs
2018-MDD/DE-033/C
Certificate
MDD Annex II Section 4·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·2 Basic UDI-DIs
2020-MDD/QS-037/A
Certificate
MDD Annex II (excluding section 4)·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·5 Basic UDI-DIs
2018-MDD/QS-034C
Certificate
MDD Annex II (excluding section 4)·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·1 Basic UDI-DI
170030QS/NB
Certificate
MDD Annex II (excluding section 4)·Hangzhou Singclean Medical Products Co., Ltd.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·56 Basic UDI-DIs
170031CN/NB
Certificate
MDD Annex II Section 4·Hangzhou Singclean Medical Products Co., Ltd.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·56 Basic UDI-DIs
12024-2018-CE-RGC-NA-PS
Certificate
MDD Annex II (excluding section 4)·Hangzhou Singclean Medical Products Co., Ltd.·DNV Product Assurance AS·19 Basic UDI-DIs
12027-2018-CE-RGC-NA-PS
Certificate
MDD Annex II Section 4·Hangzhou Singclean Medical Products Co., Ltd.·DNV Product Assurance AS·18 Basic UDI-DIs