Identity
- Trade Name
- Truenat GBS EUDAMED
- Device Name
- Truenat GBS EUDAMED
- Model / Reference
- 601240025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908020139477 EUDAMED
- Basic UDI-DI
- B-08908020139477 EUDAMED
- EMDN Code
- W0105011699 BACTERIOLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Truenat GBS by Molbio Diagnostics Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08908020139477 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Molbio Diagnostics Limited
- EUDAMED SRN
- IN-MF-000028386
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 3a2b66ea-77c0-4a5e-8d75-032eefd6d405 61 fields · synced Jul 8, 2026