Identity
- Trade Name
- Truelab® Quattro EUDAMED
- Device Name
- Truelab® Quattro Real Time Quantitative micro PCR Analyzer EUDAMED
- Model / Reference
- 603023001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908007989965 EUDAMED
- Basic UDI-DI
- 8908007989965DD EUDAMED
- Direct Marketing DI
- 08908007989965 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
- Germany 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® Quattro 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 | 8908007989965DD | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Molbio Diagnostics Limited
- EUDAMED SRN
- IN-MF-000028386
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 6da18605-3404-491d-9794-688044be0932 61 fields · synced Jul 28, 2026