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Real time PCR Kit for Monkeypox Virus
EUDAMEDClass IVD General (EU MDR)
Ref 529012/529013Model 48 Rxns/kit ，96 Rxns/kit
Identity
- Device Name
- Real time PCR Kit for Monkeypox Virus EUDAMED
- Model / Reference
- 48 Rxns/kit ，96 Rxns/kit EUDAMED529012/529013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-529012PL EUDAMED
- Basic UDI-DI
- B-529012PL EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
Real time PCR Kit for Monkeypox Virus by Shenzhen Lifotronic Technology 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-529012PL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED b4e29b75-343b-4542-93ca-ab74a3d502f9 61 fields · synced Jun 17, 2026