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Trueprep® AUTO Universal Sample Pre-treatment Pack
EUDAMEDClass A (EU MDR)
Ref 60205AB05, 60205AB20, 60205AB25, 60205AB50
Identity
- Trade Name
- Trueprep® AUTO Universal Sample Pre-treatment Pack EUDAMED
- Device Name
- Trueprep® AUTO Universal Sample Pre-treatment Pack EUDAMED
- Model / Reference
- 60205AB05, 60205AB20, 60205AB25, 60205AB50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908020139910 EUDAMED
- Basic UDI-DI
- 89080201395835B 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 Sample Pre-treatment Pack by Molbio Diagnostics Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- 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 | 89080201395835B | 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 1d90ea5b-dd99-4acb-8fb1-bf3a98a86f1b 61 fields · synced Aug 3, 2026
- EUDAMED 1d90ea5b-dd99-4acb-8fb1-bf3a98a86f1b-1 61 fields · synced Jun 10, 2026