Public EUDAMED Search

EUDAMED Device Search

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

Last updated

23.09.2026 04:15

Sync status

Successful

Device

3540602

Actor

47793

Certificate

3399

Active filter:Certificate number:IX 2074650-1

4 device results listed.

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IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN
CN-MF-000002170
UDI-DI
06952804804558
Basic UDI-DI
69528048A463101ZT
Reference
A4631011
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
22.07.2026 23:09
IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN
CN-MF-000002170
UDI-DI
06952804837174
Basic UDI-DI
69528048A463101ZT
Reference
A4631021
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
22.07.2026 22:55
06952804825638

Strip, Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN
CN-MF-000002170
UDI-DI
06952804825638
Basic UDI-DI
69528048A463101ZT
Reference
A4631011, A46310120, A46310140, A4631021, A46310220, A46310240; A46300120, A46300140, A46300220, A46300240
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Malta
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 12:32
IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN
CN-MF-000002170
UDI-DI
06952804809720
Basic UDI-DI
69528048A463101ZT
Reference
A46310120
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Netherlands
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 12:26