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SURFSeq 5000 Dx Universial Reaction Kit for Sequencing
EUDAMEDClass A (EU MDR)
Ref S000223Model FCM 100/200/300 cycles,FCH 50/100/200/300 cycles,SURF FCM 100/200/300 cycles,SURF FCH 50/100/200/300 cycles,SURF FCP 50/100/200/300 cycles
Identity
- Device Name
- SURFSeq 5000 Dx Universial Reaction Kit for Sequencing EUDAMED
- Model / Reference
- FCM 100/200/300 cycles,FCH 50/100/200/300 cycles,SURF FCM 100/200/300 cycles,SURF FCH 50/100/200/300 cycles,SURF FCP 50/100/200/300 cycles EUDAMEDS000223 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583414 EUDAMED
- Basic UDI-DI
- 697496858BR01SURF50005C 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
SURFSeq 5000 Dx Universial Reaction Kit for Sequencing 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 | 697496858BR01SURF50005C | 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 6da9ada2-a78b-4bb4-b566-21cf88fabcfa 61 fields · synced Jun 19, 2026