← Back to catalogue
Twenty Bloodstream Pathogenic Microorganisms and Drug Resistance Genes Detectio…
EUDAMEDClass IVD General (EU MDR)
Ref 2000236Model MP02
Identity
- Device Name
- Twenty Bloodstream Pathogenic Microorganisms and Drug Resistance Genes Detection Kit (Digital PCR Method） EUDAMED
- Model / Reference
- MP02 EUDAMED2000236 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975578360143 EUDAMED
- Basic UDI-DI
- B-06975578360143 EUDAMED
- EMDN Code
- W0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER 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
Twenty Bloodstream Pathogenic Microorganisms and Drug Resistance Genes Detectio… 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-06975578360143 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pilot Gene Technology (Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000023002
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 43eabb23-6895-4b23-bc63-ad7506f3f34c 61 fields · synced Jun 19, 2026