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Multiplex Real time PCR Kit for Monkeypox Virus and Central/West African Clade …
EUDAMEDClass IVD General (EU MDR)
Ref 529010/ 529011Model 48 Rxns/kit, 96 Rxns/kit
Identity
- Device Name
- Multiplex Real time PCR Kit for Monkeypox Virus and Central/West African Clade Typing EUDAMED
- Model / Reference
- 48 Rxns/kit, 96 Rxns/kit EUDAMED529010/ 529011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06970341686420RT EUDAMED
- Basic UDI-DI
- B-06970341686420RT 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
Multiplex Real time PCR Kit for Monkeypox Virus and Central/West African Clade … by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD…
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-06970341686420RT | 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 85a5078b-6e6c-4502-b768-23c8b605bd48 61 fields · synced Jul 20, 2026