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Sources: EU EUDAMED, US FDA
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EU-TDA-FI-20642-800030-2025-1
Certificate
IVDR Technical Documentation·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·Sertio Oy·1 Basic UDI-DI
DE/CA20/01-IVD-Luxuslebenswelt-1187/22
Certificate
IVDD Annex IV (excluding sections 4, 6)·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
No. 1434-IVDD-055/2022
Certificate
IVDD Annex III Section 6·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs
NO.VCQ 003706 0003 Rev.00
Certificate
IVDD Annex IV (excluding sections 4, 6)·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
No. 1434-IVDD-055/2022
Certificate
IVDD Annex IV (excluding sections 4, 6)·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·12 Basic UDI-DIs
No. 1434-IVDD-057/2022
Certificate
IVDD Annex IV (excluding sections 4, 6)·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·7 Basic UDI-DIs
V1 061788 0008
Certificate
IVDD Annex IV (excluding sections 4, 6)·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
No. V1 061788 0008
Certificate
IVDD Annex IV (excluding sections 4, 6)·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
KR19/81826212
Certificate
MDD Annex II Section 4·POLYTOUCH Co., Ltd.·SGS Belgium NV·1 Basic UDI-DI
1434-MDD-149/2021
Certificate
MDD Annex II Section 4·RFBio Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs
0528GB14191212
Certificate
MDD Annex V·OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH·DNV MEDCERT GmbH·1 Basic UDI-DI
0528GB414191212
Certificate
MDD Annex V·OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH·DNV MEDCERT GmbH·1 Basic UDI-DI