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Human Monkeypox Virus (MPV) Real Time PCR Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref MDK021415T
Identity
- Trade Name
- Human Monkeypox Virus (MPV) Real Time PCR Assay Kit EUDAMED
- Model / Reference
- MDK021415T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792054059 EUDAMED
- Basic UDI-DI
- B-06971792054059 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - 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
Human Monkeypox Virus (MPV) Real Time PCR Assay Kit by Hangzhou Realy Tech 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-06971792054059 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 40cfb7b2-f69f-4825-b516-b9f2be00e9f1 61 fields · synced Jun 19, 2026