Identity
- Trade Name
- M-prep - DNA Sample Preparation Kit EUDAMED
- Device Name
- M-prep - DNA Sample Preparation Kit EUDAMED
- Model / Reference
- 281110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840733101823 EUDAMED
- Basic UDI-DI
- 008407331ALETHIACLC011RE EUDAMED
- Direct Marketing DI
- 00840733101823 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
- Italy 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
M-prep - DNA Sample Preparation Kit by Meridian Bioscience Inc. — 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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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 | 008407331ALETHIACLC011RE | Class A | Active |
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Manufacturer
- Manufacturer
- Meridian Bioscience Inc.
- EUDAMED SRN
- US-MF-000044096
- Authorised Representative
- Meridian Bioscience Europe S.r.l. IT-AR-000010460
Sources (1)
- EUDAMED a0fe1794-5e01-4270-ad2d-d7868b388911 61 fields · synced Jun 20, 2026