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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.

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

W.H.P.M. Bioresearch & Technology Co., Ltd.

Manufacturer
🇨🇳 China·27 Basic UDI-DIs·27 Devices·7 Importers·TÜV Rheinland LGA Products GmbH

Hangzhou Laihe Biotech Co., Ltd.

Manufacturer
🇨🇳 China·6 Basic UDI-DIs·6 Devices·2 Importers·CeCert Sp. z o.o. and TÜV Rheinland LGA Products GmbH

CeCert/077/W/E.1

Certificate
IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

244409553-200

Certificate
IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

HL 2074650-1

Certificate
IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

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

HL 2101523-1

Certificate
IVDD Annex IV (excluding sections 4, 6)·W.H.P.M. Bioresearch & Technology Co., Ltd.·TÜV Rheinland LGA Products GmbH·21 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

HL 202746520-1

Certificate
IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

HL 202746520-1

Certificate
IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

HL 2069313-1

Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Laihe Biotech Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

SARS-CoV-2 Antigen Rapid Tests for Self-Testing

Device
EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Device
EU IVDD · Eu Ivd Self Testing ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·On the market

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Device
EU IVDD · Eu Ivd Self Testing ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·On the market

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Device
EU IVDD · Eu Ivd Self Testing ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·On the market