← Back to catalogue
Monkeypox Virus Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 1 Test/KitRef 5 Tests/KitRef 40 Tests/KitModel 40 Tests/Kit Ref 20 Tests/Kit
Identity
- Device Name
- Monkeypox Virus Antigen Rapid Test EUDAMED
- Model / Reference
- 1 Test/Kit EUDAMED5 Tests/Kit EUDAMED40 Tests/Kit EUDAMED20 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975166204569 EUDAMED06975166204576 EUDAMED06975166204590 EUDAMED06975166204583 EUDAMED
- Basic UDI-DI
- B-06975166204569 EUDAMEDB-06975166204576 EUDAMEDB-06975166204590 EUDAMEDB-06975166204583 EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMEDW0105099008 MONKEYPOX VIRUS / MPOX RT & POC 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
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Monkeypox Virus 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-06975166204569 | 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 (5)
- EUDAMED 7eaadf04-6b8c-4bf9-ba3e-73f3a9176e33 61 fields · synced Jul 27, 2026
- EUDAMED 9652e4de-4b46-4826-9244-de6b1cb58d1e 61 fields · synced Jul 13, 2026
- EUDAMED 7f192077-a284-45f0-b61c-401cd4f17d3a 61 fields · synced Jul 19, 2026
- EUDAMED c30b13e5-bdad-4760-80a3-a6990ef4d37d 61 fields · synced Jul 25, 2026
- EUDAMED c634edf2-3b64-45ea-85ab-116f5b490412 61 fields · synced Jul 27, 2026