Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

EuroGen Strep A Rapid Test

UDI-DI 16976838235352Basic UDI-DI 697683823P201900F9

Class C · IVDR · GenSure Biotech Inc.

Scan an inventory CSV

Identification

Model: —
EMDN: W0105090103
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

V76 126886 0005

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2025-07-11 · Expiry 2030-07-10

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

GenSure Biotech Inc.

SRN CN-MF-000028354

CN · Shanghai

manufacturer

Authorised representative: RIOMAVIX SOCIEDAD LIMITADA (ES-AR-000001202)

Related UDI-DIs

DIAGOTEC Strep A Rapid Test 06976838234907
DIAGOTEC Strep A Rapid Test 06976838234914
DyonStrepA Strep A Rapid Test 06976838234891
EuroGen Strep A Rapid Test 16976838235390
EuroGen Strep A Rapid Test 16976838235383
EuroGen Strep A Rapid Test 16976838235376
EuroGen Strep A Rapid Test 16976838235369
GenSure Strep A Rapid Test 16976838230371
GenSure Strep A Rapid Test 16976838230388
GenSure Strep A Rapid Test 16976838230395
GenSure Strep A Rapid Test 06976838234754
GenSure Strep A Rapid Test 16976838230401

Showing 12 of 13 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/eurogen-strep-a-rapid-test-5352 · UDI page: /udi/16976838235352

All devices from GenSure Biotech Inc.

Scan an inventory CSV