Identity
- Trade Name
- PRIME MDx DNA/RNA Extraction kit 2 x48 rxn EUDAMED
- Device Name
- PRIME MDx DNA/RNA Extraction kit 2 x48 rxn EUDAMED
- Model / Reference
- 56446 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08012992564462 EUDAMED
- Basic UDI-DI
- 8012992PMDXEKYY EUDAMED
- Direct Marketing DI
- 08012992564462 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
PRIME MDx DNA/RNA Extraction kit 2 x48 rxn by A. MENARINI Diagnostics S.r.l. — 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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- 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 | 8012992PMDXEKYY | Class A | Active |
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Manufacturer
- Manufacturer
- A. MENARINI Diagnostics S.r.l.
- EUDAMED SRN
- IT-MF-000023427
Sources (1)
- EUDAMED 5732e205-061f-45ca-8a49-d40cf5a92848 61 fields · synced Jul 9, 2026