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GeneMind
EUDAMEDClass A (EU MDR)
Ref S000495Model S-1 FCL-D 100-D,S-1 FCL 100,S-1 FCL 300,S-1 FCM-D 100-D,S-1 FCM 100,S-1 FCM 300
Identity
- Trade Name
- GeneMind EUDAMED
- Device Name
- FASTASeq S Dx Universal Reaction Kit for Sequencing EUDAMED
- Model / Reference
- S-1 FCL-D 100-D,S-1 FCL 100,S-1 FCL 300,S-1 FCM-D 100-D,S-1 FCM 100,S-1 FCM 300 EUDAMEDS000495 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583858 EUDAMED
- Basic UDI-DI
- 697496858BZ01UU EUDAMED
- Direct Marketing DI
- 06974968583858 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - 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 | 697496858BZ01UU | 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 d0a8dd24-724e-49d2-9dfe-431524abeac7 61 fields · synced Jun 19, 2026