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GeneMind
EUDAMEDClass A (EU MDR)
Ref S000394Model FASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-D
Identity
- Trade Name
- GeneMind EUDAMED
- Device Name
- Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing） EUDAMED
- Model / Reference
- FASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-D EUDAMEDS000394 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583612 EUDAMED
- Basic UDI-DI
- 697496858FASTASeq-Kit2W EUDAMED
- Direct Marketing DI
- 06974968583612 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 | 697496858FASTASeq-Kit2W | 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 2337b104-2317-445a-bea8-3bc66b52f61c 61 fields · synced Jun 18, 2026