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Sequencing Reaction Universal Kit (Semiconductor Sequencing)
EUDAMEDClass A (EU MDR)
Ref 4C4R/kitModel 4C4R/kit, 4C8R /kit, 8C8R/kit
Identity
- Device Name
- Sequencing Reaction Universal Kit (Semiconductor Sequencing) EUDAMED
- Model / Reference
- 4C4R/kit, 4C8R /kit, 8C8R/kit EUDAMED4C4R/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974776970307 EUDAMED
- Basic UDI-DI
- 697477697SRUK01A4 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Sequencing Reaction Universal Kit (Semiconductor Sequencing) by CapitalBio Genomics 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 | 697477697SRUK01A4 | Class A | Active |
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Manufacturer
- Manufacturer
- CapitalBio Genomics Co., Ltd.
- EUDAMED SRN
- CN-MF-000027716
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4b8a70f9-5075-4fe8-9c71-f40105bc7485 61 fields · synced Aug 3, 2026