Identity
- Trade Name
- Trueprep® AUTO v2 EUDAMEDTrueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit EUDAMED
- Device Name
- Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device EUDAMEDTrueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit EUDAMED
- Model / Reference
- 603042001 EUDAMED60207AR50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908007989972 EUDAMED08908007989859 EUDAMED
- Basic UDI-DI
- 8908007989972DA EUDAMED8908007989859DD EUDAMED
- Direct Marketing DI
- 08908007989972 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMEDW0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMEDBelgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
No
EUDAMED
Trueprep® AUTO v2 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 | 8908007989972DA | 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 (2)
- EUDAMED cde928a9-2b26-4e2d-befe-c41c8964a2f5 61 fields · synced Jul 18, 2026
- EUDAMED bc1a6ece-b05c-4cd5-ae06-3d3936ce8f7b 61 fields · synced May 18, 2026