← Back to catalogue
Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencin…
EUDAMEDClass IVD General (EU MDR)
Ref L000044Model 24 tests/kit
Identity
- Trade Name
- Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing) EUDAMED
- Device Name
- Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing) EUDAMED
- Model / Reference
- 24 tests/kit EUDAMEDL000044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583179 EUDAMED
- Basic UDI-DI
- B-06974968583179 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencin… by GeneMind Biosciences Co., Ltd. — Class IVD General — IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974968583179 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GeneMind Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000025785
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 1230a84e-2ac2-421a-a01e-7f493fab3b80 61 fields · synced Jun 18, 2026