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Allfastra Respiratory Bacteria Panel (7) Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJB110702NW-50TRef YJB110702NW-25T
Identity
- Trade Name
- Allfastra Respiratory Bacteria Panel (7) Real Time PCR Kit EUDAMED
- Device Name
- Allfastra Respiratory Bacteria Panel (7) Real Time PCR Kit EUDAMED
- Model / Reference
- YJB110702NW-50T EUDAMEDYJB110702NW-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-YJB110702NW-50TVJ EUDAMEDD-YJB110702NW-25TVJ EUDAMED
- Basic UDI-DI
- B-YJB110702NW-50TVJ EUDAMEDB-YJB110702NW-25TVJ 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 (7) 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-YJB110702NW-50TVJ | 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 fdbf1990-7e96-4395-8f3d-ff94cdcd6007 61 fields · synced Jul 12, 2026
- EUDAMED 63541035-4c63-4219-9426-c14e09f72b6d 61 fields · synced May 18, 2026