Identity
- Trade Name
- pureNA® Cell-Free DNA Isolation Kit EUDAMED
- Device Name
- pureNA® Cell-Free DNA Isolation Kit EUDAMED
- Model / Reference
- CFDNA-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060536830576 EUDAMED
- Basic UDI-DI
- 506053683CFDNA1ZS EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Czechia 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
No
EUDAMED
pureNA® Cell-Free DNA Isolation Kit by EntroGen, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 506053683CFDNA1ZS | Class A | Active |
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Manufacturer
- Manufacturer
- EntroGen, Inc.
- EUDAMED SRN
- US-MF-000022721
- Authorised Representative
- TANJA TOPOVSEK S.P. SI-AR-000022518
Sources (1)
- EUDAMED 9d4876f0-0060-4d20-bc0c-6f2abbcc6f07 61 fields · synced Jun 19, 2026