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Bacillus Anthracis Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJB60101NW-50TRef YJB60101NW-25T
Identity
- Trade Name
- Bacillus Anthracis Real Time PCR Kit EUDAMED
- Device Name
- Bacillus Anthracis Real Time PCR Kit EUDAMED
- Model / Reference
- YJB60101NW-50T EUDAMEDYJB60101NW-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-YJB60101NW-50TYH EUDAMEDD-YJB60101NW-25TYH EUDAMED
- Basic UDI-DI
- B-YJB60101NW-50TYH EUDAMEDB-YJB60101NW-25TYH 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
Bacillus Anthracis 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-YJB60101NW-50TYH | 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 469998bb-4d06-4e65-a517-2ad2867dc3cc 61 fields · synced Jul 9, 2026
- EUDAMED 82ede28f-32a0-445f-a97f-66986fb9fa96 61 fields · synced May 16, 2026