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Trueprep® AUTO Universal Cartridge Based Sample Prep Kit
EUDAMEDClass A (EU MDR)
Ref 60203AR25, 60203AR50
Identity
- Trade Name
- Trueprep® AUTO Universal Cartridge Based Sample Prep Kit EUDAMED
- Device Name
- Trueprep® AUTO Universal Cartridge Based Sample Prep Kit EUDAMED
- Model / Reference
- 60203AR25, 60203AR50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908007989880 EUDAMED
- Basic UDI-DI
- 8908007989880D4 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Trueprep® AUTO Universal Cartridge Based Sample Prep Kit by Molbio Diagnostics Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 8908007989880D4 | 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 (2)
- EUDAMED b5a7bc37-dd13-43af-a45c-13e03febf091 61 fields · synced Jun 19, 2026
- EUDAMED b5a7bc37-dd13-43af-a45c-13e03febf091-1 61 fields · synced Jun 10, 2026