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InfectID-BSI B3 Bacterial Detection Kit
EUDAMEDClass C (EU MDR)
Ref MRB700Model MRB1300
by Microbio Ltd
Identity
- Trade Name
- InfectID-BSI B3 Bacterial Detection Kit EUDAMED
- Device Name
- InfectID-BSI Bacterial and Yeast Assay Kit EUDAMED
- Model / Reference
- MRB1300 EUDAMEDMRB700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09309001216054 EUDAMED
- Basic UDI-DI
- 9309001216InfectID-BSILL EUDAMED
- Direct Marketing DI
- 09309001216054 EUDAMED
- EMDN Code
- W0105070202 BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
InfectID-BSI B3 Bacterial Detection Kit by Microbio Ltd — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 9309001216InfectID-BSILL | Class C | Active |
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Manufacturer
- Manufacturer
- Microbio Ltd
- EUDAMED SRN
- AU-MF-000033903
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED 6d3a16c0-e55b-4668-b2d6-580c31977f1e 61 fields · synced Jul 28, 2026