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Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)
EUDAMEDClass IVD General (EU MDR)
Ref L000050Model 24 tests/kitRef L000051Model 48 tests/kit
Identity
- Trade Name
- Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method) EUDAMED
- Device Name
- Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method) EUDAMED
- Model / Reference
- 24 tests/kit EUDAMEDL000050 EUDAMED48 tests/kit EUDAMEDL000051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583223 EUDAMED06974968583230 EUDAMED
- Basic UDI-DI
- B-06974968583223 EUDAMEDB-06974968583230 EUDAMED
- EMDN Code
- W0106010399 CHROMOSOMAL DISORDERS TESTS - 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
Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method) by GeneMind Biosciences Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974968583223 | Class IVD General | 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 6ca1a41d-3c69-4eb5-818a-5d6f346e9785 61 fields · synced Aug 1, 2026
- EUDAMED 480270b9-014b-4cf5-89c7-8bd6dd0bb4bf 61 fields · synced May 18, 2026