Identity
- Trade Name
- Truelab® Duo EUDAMED
- Device Name
- Truelab® Duo Real Time Quantitative micro PCR Analyzer EUDAMED
- Model / Reference
- 603022001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908007989958 EUDAMED
- Basic UDI-DI
- 8908007989958DG EUDAMED
- Direct Marketing DI
- 08908007989958 EUDAMED
- EMDN Code
- W02050399 NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Truelab® Duo by Molbio Diagnostics Limited — Class A — 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 | 8908007989958DG | Class A | 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 550fcf5f-ac1b-441d-aac1-af8acd26884b 61 fields · synced Jul 12, 2026