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Herpes Simplex Virus -I/II IgM (HSV-I/II IgM) Assay Reagent Kit (CMIA)

Device
EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

General Chemistry III Lyophilized Kit 15

Device
EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·On the market

Shenzhen Microprofit Biotech Co., Ltd.

Manufacturer
🇨🇳 China·13 Basic UDI-DIs·13 Devices·9 Importers·CeCert Sp. z o.o., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV SÜD Product Service GmbH

Hangzhou Fanttest Biotech Co., Ltd.

Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Zhejiang Nurotron Biotechnology Co., Ltd.

Manufacturer
🇨🇳 China·60 Basic UDI-DIs·60 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

NeuroSafe Medical Co., Ltd.

Manufacturer
🇨🇳 China·28 Basic UDI-DIs·28 Devices·2 Importers·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Shanghai REACH Medical Instrument Co., Ltd

Manufacturer
🇨🇳 China·246 Basic UDI-DIs·246 Devices·2 Importers·TÜV SÜD Product Service GmbH, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Jiangsu Haize Medical Scientific Development Co., Ltd.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

Changzhou Intl. Trade & Enterprises Cooperative Co.,Ltd.

Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices·7 Importers·TÜV Rheinland LGA Products GmbH

Shandong Haidike Medical Products Co Ltd

Manufacturer
🇨🇳 China·6 Basic UDI-DIs·6 Devices·1 Importer·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

Manufacturer
🇨🇳 China·29 Basic UDI-DIs·29 Devices·4 Importers·Sertio Oy, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

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

CeCert/091/W/E.1

Certificate
IVDD Annex III Section 6·Shenzhen Microprofit Biotech Co., Ltd.·CeCert Sp. z o.o.·3 Basic UDI-DIs

CeCert/092/W/E.2

Certificate
IVDD Annex III Section 6·Shenzhen Microprofit Biotech Co., Ltd.·CeCert Sp. z o.o.·3 Basic UDI-DIs

1434-IVDD-081/2022

Certificate
IVDD Annex III Section 6·Shenzhen Microprofit Biotech Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

1434-IVDD-263/2022

Certificate
IVDD Annex III Section 6·Hangzhou Fanttest Biotech Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

M.2021.106.14633-1

Certificate
MDD Annex II Section 4·NeuroSafe Medical Co., Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·28 Basic UDI-DIs

691392

Certificate
AIMDD Annex II Section 4·Zhejiang Nurotron Biotechnology Co., Ltd.·BSI Group The Netherlands B.V.·59 Basic UDI-DIs

Enduro Earhook

Certificate
AIMDD Annex II Section 4·Zhejiang Nurotron Biotechnology Co., Ltd.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

HD 2057087-1

Certificate
MDD Annex II (excluding section 4)·Changzhou Intl. Trade & Enterprises Cooperative Co.,Ltd.·TÜV Rheinland LGA Products GmbH·3 Basic UDI-DIs