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Four Bacteria Combined Nucleic Acid Detection Kit (Digital PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 2000265Model P11
Identity
- Device Name
- Four Bacteria Combined Nucleic Acid Detection Kit (Digital PCR Method) EUDAMED
- Model / Reference
- P11 EUDAMED2000265 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975578360204 EUDAMED
- Basic UDI-DI
- B-06975578360204 EUDAMED
- EMDN Code
- W0105070202 BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Four Bacteria Combined Nucleic Acid Detection Kit (Digital PCR Method) by Pilot Gene Technology (Hangzhou) Co., Ltd — 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-06975578360204 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Pilot Gene Technology (Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000023002
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED a1ddcac7-496d-4524-befd-b71c4552badc 61 fields · synced Jul 26, 2026