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Monkeypox Virus Varicella-zoster Virus/Variola Virus Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJC70303NW-50TRef YJC70303NW-25T
Identity
- Trade Name
- Monkeypox Virus Varicella-zoster Virus/Variola Virus Real Time PCR Kit EUDAMED
- Device Name
- Monkeypox Virus Varicella-zoster Virus/Variola Virus Real Time PCR Kit EUDAMED
- Model / Reference
- YJC70303NW-50T EUDAMEDYJC70303NW-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-YJC70303NW-50T58 EUDAMEDD-YJC70303NW-25T58 EUDAMED
- Basic UDI-DI
- B-YJC70303NW-50T58 EUDAMEDB-YJC70303NW-25T58 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA 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
Yes
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 Varicella-zoster Virus/Variola Virus Real Time PCR Kit by Jiangsu Bioperfectus Technologies Co., Ltd. — Class IVD General — IVDD — listed in…
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-YJC70303NW-50T58 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 73a9b05b-df17-4e5a-8dff-59c13323b5f2 61 fields · synced Oct 6, 2026
- EUDAMED efaee6e1-e8b5-41ac-acf5-9648209ae23a 61 fields · synced May 16, 2026