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Allfastra Respiratory Bacteria Panel (3) Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJB20305NW-25TRef YJB20305NW-50T
Identity
- Trade Name
- Allfastra Respiratory Bacteria Panel (3) Real Time PCR Kit EUDAMED
- Device Name
- Allfastra Respiratory Bacteria Panel (3) Real Time PCR Kit EUDAMED
- Model / Reference
- YJB20305NW-25T EUDAMEDYJB20305NW-50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-YJB20305NW-25TY7 EUDAMEDD-YJB20305NW-50TY7 EUDAMED
- Basic UDI-DI
- B-YJB20305NW-25TY7 EUDAMEDB-YJB20305NW-50TY7 EUDAMED
- EMDN Code
- W0105011699 BACTERIOLOGY - 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
Allfastra Respiratory Bacteria Panel (3) Real Time PCR Kit by Jiangsu Bioperfectus Technologies 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-YJB20305NW-25TY7 | 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 (2)
- EUDAMED 8dd2d6f3-add0-4506-b206-1c2b35d1fbbc 61 fields · synced Oct 6, 2026
- EUDAMED 7a9dbc63-1f1c-42b8-ab1c-9bfbb4f7d8ca 61 fields · synced May 18, 2026