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Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)
EUDAMEDClass IVD General (EU MDR)
Ref MPX00101Model MPX00201
Identity
- Device Name
- Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) EUDAMED
- Model / Reference
- MPX00201 EUDAMEDMPX00101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975146600169 EUDAMED
- Basic UDI-DI
- B-06975146600169 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - 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
Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) by BioDetect（Xiamen）Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06975146600169 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- BioDetect（Xiamen）Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001098
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 802e0755-6d91-4f81-a582-4f4eb0d315f5 61 fields · synced Jun 18, 2026