← Back to catalogue
Neisseria Gonorrhoeae Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 1 Test/KitRef 5 Tests/KitRef 20 Tests/Kit
Identity
- Device Name
- Neisseria Gonorrhoeae Antigen Rapid Test EUDAMED
- Model / Reference
- 1 Test/Kit EUDAMED5 Tests/Kit EUDAMED20 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975166204521 EUDAMED06975166204538 EUDAMED06975166204545 EUDAMED
- Basic UDI-DI
- B-06975166204521 EUDAMEDB-06975166204538 EUDAMEDB-06975166204545 EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMEDW0105090199 BACTERIOLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Neisseria Gonorrhoeae Antigen Rapid Test by Avioq Bio-tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975166204521 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avioq Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048146
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 1356ca21-5fbc-460c-9ae6-beb3b4b46fc6 61 fields · synced Jul 21, 2026
- EUDAMED 66c3e5a4-7f2d-4865-809e-813f7cedeee6 61 fields · synced Jul 9, 2026
- EUDAMED 927aa2bb-b875-4d97-afb6-dfd43710f530 61 fields · synced Jul 9, 2026
- EUDAMED 2c72e4a0-b7bc-4517-a337-9dd0989ba21e 61 fields · synced Jul 21, 2026