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Universal Reaction Kit for Sequencing（Single Molecule Direct Sequencing）
EUDAMEDClass A (EU MDR)
Ref S000046Model D9T,SE036；D9T,SE050Ref S000045
Identity
- Trade Name
- Universal Reaction Kit for Sequencing（Single Molecule Direct Sequencing） EUDAMED
- Device Name
- Universal Reaction Kit for Sequencing（Single Molecule Direct Sequencing） EUDAMED
- Model / Reference
- D9T,SE036；D9T,SE050 EUDAMEDS000046 EUDAMEDS000045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583025 EUDAMED06974968583018 EUDAMED
- Basic UDI-DI
- 697496858S-Kit37 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（Single Molecule Direct 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 | 697496858S-Kit37 | 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 (2)
- EUDAMED d9edd18f-ba72-43df-98bb-d8c26bf1a37b 61 fields · synced Jul 17, 2026
- EUDAMED bf2b0f26-ced8-44ea-ab92-9d5448c2f330 61 fields · synced May 17, 2026