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Monkeypox Virus Antigen Rapid Test Device
EUDAMEDClass IVD General (EU MDR)
Ref 3042400501Model MPXV-201（1pcs）
Identity
- Device Name
- Monkeypox Virus Antigen Rapid Test Device EUDAMED
- Model / Reference
- MPXV-201（1pcs） EUDAMED3042400501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69717712001017M EUDAMED
- Basic UDI-DI
- B-69717712001017M EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Monkeypox Virus Antigen Rapid Test Device by Hangzhou Lysun Biotechnology 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-69717712001017M | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lysun Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000010254
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d1ddb575-7eda-4a8e-99b5-3eaad36c6e1b 61 fields · synced Jul 9, 2026