ITS - BEUDAMED

TROPONIN I/T

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

Specific Diagnostics

Manufacturer

🇺🇸 United States·1 Importer

InTec PRODUCTS, INC.

Manufacturer

🇨🇳 China·25 Basic UDI-DIs·25 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

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

MDT Int'l SA

Manufacturer

🇨🇭 Switzerland·7 Basic UDI-DIs·7 Devices·1 Importer·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', DEKRA Certification B.V., and DEKRA Certification B.V.

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.

Atomo Diagnostics Limited

Manufacturer

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

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

BPR Medical Limited

Manufacturer

44 Basic UDI-DIs·44 Devices·3 Importers·SGS Belgium NV

Yelatma Instrument-Making Enterprise Joint-Stock Company

Manufacturer

🇷🇺 Russian Federation·9 Basic UDI-DIs·20 Devices·TÜV NORD CERT GmbH

ORAgene (Swab-based DNA & Dx Collection Device)

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

AAV5 NAb Test Specimen Collection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Precision for Medicine, Inc.·1 device

AutoLumo analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·2 devices