Identity
- Trade Name
- GeneMind EUDAMED
- Device Name
- Cell-Free DNA Isolation Kit (Pre-packaged) EUDAMED
- Model / Reference
- 96 tests/kit EUDAMEDL000108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583551 EUDAMED
- Basic UDI-DI
- 69749685896RXNSD EUDAMED
- Direct Marketing DI
- 06974968583551 EUDAMED
- EMDN Code
- W01010499 MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
GeneMind by GeneMind Biosciences Co., Ltd. — 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 | 69749685896RXNSD | Class A | Active |
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Manufacturer
- Manufacturer
- GeneMind Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000025785
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 147c8d65-9af1-4443-bac4-5fc857080c1e 61 fields · synced Jun 18, 2026