← Back to catalogue
Trueprep ® AUTO MTB Sample Pre-treatment Pack
EUDAMEDClass A (EU MDR)
Ref 60204AS05, 60204AS20, 60204AS25, 60204AS50
Identity
- Trade Name
- Trueprep ® AUTO MTB Sample Pre-treatment Pack EUDAMED
- Device Name
- Trueprep® AUTO MTB Sample Pre-treatment Pack EUDAMED
- Model / Reference
- 60204AS05, 60204AS20, 60204AS25, 60204AS50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908020139903 EUDAMED
- Basic UDI-DI
- 89080201395765E 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 MTB 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.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- 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 | 89080201395765E | 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 a0334b05-e1d7-4bb5-a7f8-063b16578e2d 61 fields · synced Jun 19, 2026
- EUDAMED a0334b05-e1d7-4bb5-a7f8-063b16578e2d-1 61 fields · synced Jun 9, 2026