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Sino Medical Sciences Technology Inc.

Manufacturer
🇨🇳 China·42 Basic UDI-DIs·42 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

Chungwoo Co., Ltd.

Manufacturer
🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·2 Importers·3EC International a.s. and 3EC International a.s.

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

Takagi seiko

Manufacturer
🇯🇵 Japan·14 Basic UDI-DIs·29 Devices·4 Importers·SGS Belgium NV, SGS FIMKO OY, SGS FIMKO OY, and SGS FIMKO OY

CUREXO, INC.

Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·BUREAU VERITAS ITALIA S.P.A.

Shenzhen Lifetech Cardio Medical Electronics Co.,Ltd.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·1 Importer·BSI Group The Netherlands B.V.

Maccura Biotechnology Co., Ltd.

Manufacturer
🇨🇳 China·1794 Basic UDI-DIs·1799 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service 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

2225435DE01

Certificate
MDD Annex II Section 4·Sino Medical Sciences Technology Inc.·DEKRA Certification B.V.·32 Basic UDI-DIs

2225435DE01

Certificate
MDD Annex II Section 4·Sino Medical Sciences Technology Inc.·DEKRA Certification B.V.·10 Basic UDI-DIs

244409553-200

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

2018-MDD/QS-013

Certificate
MDD Annex II (excluding section 4)·Chungwoo Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

2020-MDD/QS-093

Certificate
MDD Annex II (excluding section 4)·Chungwoo Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

2225435CE01

Certificate
MDD Annex II (excluding section 4)·Sino Medical Sciences Technology Inc.·DEKRA Certification B.V.·25 Basic UDI-DIs

2225435CE01

Certificate
MDD Annex II (excluding section 4)·Sino Medical Sciences Technology Inc.·DEKRA Certification B.V.·16 Basic UDI-DIs

2225435CE01

Certificate
MDD Annex II (excluding section 4)·Sino Medical Sciences Technology Inc.·DEKRA Certification B.V.·1 Basic UDI-DI

FI1907010

Certificate
MDD Annex II (excluding section 4)·Takagi seiko·SGS FIMKO OY·2 Basic UDI-DIs

IT288297

Certificate
MDD Annex II (excluding section 4)·CUREXO, INC.·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI

CE 698635

Certificate
MDD Annex II (excluding section 4)·Shenzhen Lifetech Cardio Medical Electronics Co.,Ltd.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

Fl19/07010

Certificate
MDD Annex II (excluding section 4)·Takagi seiko·SGS FIMKO OY·1 Basic UDI-DI