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Blood pathogens and drug resistance genes digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref 13696Model BP01-Y24
Identity
- Trade Name
- Blood pathogens and drug resistance genes digital PCR detection kit EUDAMED
- Device Name
- Blood pathogens and drug resistance genes digital PCR detection kit EUDAMED
- Model / Reference
- BP01-Y24 EUDAMED13696 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626636 EUDAMED
- Basic UDI-DI
- B-06974689626636 EUDAMED
- EMDN Code
- W0105070201 GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Blood pathogens and drug resistance genes digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — 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-06974689626636 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 183c482e-50d9-44a6-a3c9-82c9ec0b1f04 61 fields · synced Jun 19, 2026