Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

08.07.2026 13:13

Sync status

Successful

Device

2716669

Actor

47339

Certificate

3053

Active filter:Certificate number:EU-TDA-FI-43117-800031-2025

5 device results listed.

Page 1 / 1

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use
Manufacturer
BioTeke Corporation(Wuxi)Co., Ltd
Manufacturer SRN
CN-MF-000007517
UDI-DI
06974541564472
Basic UDI-DI
697454156017LA
Reference
ICA2114-7
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Spain
Safety summary (SSCP/SSP)
BTK-CE17-0606 · Rev. A3
Authorised representative
Medunion S.L.
Last updated
30.06.2026 12:13
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use
Manufacturer
BioTeke Corporation(Wuxi)Co., Ltd
Manufacturer SRN
CN-MF-000007517
UDI-DI
06974541564465
Basic UDI-DI
697454156017LA
Reference
ICA2114-7
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Spain
Safety summary (SSCP/SSP)
BTK-CE17-0606 · Rev. A3
Authorised representative
Medunion S.L.
Last updated
30.06.2026 12:13
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use
Manufacturer
BioTeke Corporation(Wuxi)Co., Ltd
Manufacturer SRN
CN-MF-000007517
UDI-DI
06974541564458
Basic UDI-DI
697454156017LA
Reference
ICA2114-7
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Spain
Safety summary (SSCP/SSP)
BTK-CE17-0606 · Rev. A3
Authorised representative
Medunion S.L.
Last updated
30.06.2026 12:13
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use
Manufacturer
BioTeke Corporation(Wuxi)Co., Ltd
Manufacturer SRN
CN-MF-000007517
UDI-DI
06974541564441
Basic UDI-DI
697454156017LA
Reference
ICA2114-7
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Spain
Safety summary (SSCP/SSP)
BTK-CE17-0606 · Rev. A3
Authorised representative
Medunion S.L.
Last updated
30.06.2026 12:13
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use
Manufacturer
BioTeke Corporation(Wuxi)Co., Ltd
Manufacturer SRN
CN-MF-000007517
UDI-DI
06974541564434
Basic UDI-DI
697454156017LA
Reference
ICA2114-7
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Spain
Safety summary (SSCP/SSP)
BTK-CE17-0606 · Rev. A3
Authorised representative
Medunion S.L.
Last updated
30.06.2026 12:13