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Monkeypox Virus Ag Test Kit
EUDAMEDClass C (EU MDR)
Ref G11821Model 25 tests/box
Identity
- Trade Name
- Monkeypox Virus Ag Test Kit EUDAMED
- Device Name
- Monkeypox Virus Ag Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDG11821 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581207 EUDAMED
- Basic UDI-DI
- 697518250G1182135 EUDAMED
- Direct Marketing DI
- 06942293581207 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
Monkeypox Virus Ag Test Kit by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250G1182135 | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 829b4bd5-0b10-411d-b647-a0c59aa9da46 61 fields · synced Jun 19, 2026