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Severe Fever with Thrombocytopenia Syndrome Virus Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJC70107NW-50T
Identity
- Trade Name
- Severe Fever with Thrombocytopenia Syndrome Virus Real Time PCR Kit EUDAMED
- Device Name
- Severe Fever with Thrombocytopenia Syndrome Virus Real Time PCR Kit EUDAMED
- Model / Reference
- YJC70107NW-50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-YJC70107NW-50T5W EUDAMED
- Basic UDI-DI
- B-YJC70107NW-50T5W 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
Yes
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
Severe Fever with Thrombocytopenia Syndrome 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-YJC70107NW-50T5W | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 850728f5-cea4-4dec-87f1-93405470f3f1 61 fields · synced Jun 18, 2026