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Bloodstream Infection Pathogen and Antimicrobial Resistance Gene Nucleic Acid D…
EUDAMEDClass IVD General (EU MDR)
Ref 2000263Model MP21
Identity
- Device Name
- Bloodstream Infection Pathogen and Antimicrobial Resistance Gene Nucleic Acid Detection Kit (Digital PCR Method) EUDAMED
- Model / Reference
- MP21 EUDAMED2000263 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975578360181 EUDAMED
- Basic UDI-DI
- B-06975578360181 EUDAMED
- EMDN Code
- W0105070502 OTHER MULTIPLE INFECTIOUS - 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
Bloodstream Infection Pathogen and Antimicrobial Resistance Gene Nucleic Acid D… by Pilot Gene Technology (Hangzhou) Co., Ltd — Class IVD General — IVDD…
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-06975578360181 | 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 5d81a804-0200-45f5-abef-b9fb356595d4 61 fields · synced Jun 18, 2026