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Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing）
EUDAMEDClass A (EU MDR)
Ref S000146Model FASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-D
Identity
- 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 EUDAMEDS000146 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583391 EUDAMED
- Basic UDI-DI
- 697496858FASTASeq-Kit2W 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
Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing） by GeneMind Biosciences Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 9b906fc8-e8ef-4e77-95a8-9eccc8753c8d 61 fields · synced Jun 19, 2026