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Francisella tularensis Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJB20143NW-25T
Identity
- Trade Name
- Francisella tularensis Real Time PCR Kit EUDAMED
- Device Name
- Francisella tularensis Real Time PCR Kit EUDAMED
- Model / Reference
- YJB20143NW-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-YJB20143NW-25TY3 EUDAMED
- Basic UDI-DI
- B-YJB20143NW-25TY3 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
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
Francisella tularensis 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-YJB20143NW-25TY3 | 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 952bfc17-5e8f-467c-b9b3-f2586358c5f7 61 fields · synced Jun 19, 2026