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Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.

Manufacturer
🇨🇳 China·5 Basic UDI-DIs·5 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Atomo Diagnostics Limited

Manufacturer
🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

ForaCare Suisse AG

Manufacturer
🇨🇭 Switzerland·22 Basic UDI-DIs·23 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Ace Medical Technology Co., Ltd.

Manufacturer
🇹🇼 Taiwan·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

Acon Biotech (Hangzhou) Co., Ltd.

Manufacturer
🇨🇳 China·101 Basic UDI-DIs·130 Devices·14 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Qingdao Hightop Biotech Co., Ltd.

Manufacturer
🇨🇳 China·14 Basic UDI-DIs·14 Devices·3 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Peptonic Medical Israel Ltd

Manufacturer
🇮🇱 Israel·1 Basic UDI-DI·1 Device·MDC MEDICAL DEVICE CERTIFICATION GMBH

MedMira Laboratories Inc.

Manufacturer
🇨🇦 Canada·6 Basic UDI-DIs·6 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

TaiDoc Technology Corporation

Manufacturer
🇹🇼 Taiwan·50 Basic UDI-DIs·53 Devices·13 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Sanway Gene Tech. Inc.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

bioLytical Laboratories Inc.

Manufacturer
🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S

fPSA Rapid Test

Device
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

PSA Rapid Test

Device
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

CancerCheck® PSA

Device
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

CancerCheck ® fPSA

Device
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

Simplitude ByMe

Device
EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

Simplitude ByMe

Device
EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

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

Jiangsu Bioperfectus Technologies Co., Ltd.

Manufacturer
🇨🇳 China·216 Basic UDI-DIs·219 Devices·5 Importers·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

GlucoX Blood Glucose Monitoring System

Device
EU IVDD · Eu Ivd Annex 2 List B ·TaiDoc Technology Corporation·On the market