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Preimplantation Genetic Testing For Aneuploidy Detection Kit（Single Molecule Di…
EUDAMEDClass IVD General (EU MDR)
Ref L000031Model 96 tests/kitRef L000030Model 32 tests/kit
Identity
- Trade Name
- Preimplantation Genetic Testing For Aneuploidy Detection Kit（Single Molecule Direct Sequencing） EUDAMED
- Device Name
- Preimplantation Genetic Testing For Aneuploidy Detection Kit（Single Molecule Direct Sequencing） EUDAMED
- Model / Reference
- 96 tests/kit EUDAMEDL000031 EUDAMED32 tests/kit EUDAMEDL000030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583117 EUDAMED06974968583100 EUDAMED
- Basic UDI-DI
- B-06974968583117 EUDAMEDB-06974968583100 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
Preimplantation Genetic Testing For Aneuploidy Detection Kit（Single Molecule Di… 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-06974968583117 | 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 3bf3f008-81b3-4ec1-b9c2-b19a4400c638 61 fields · synced Jul 27, 2026
- EUDAMED 6dad52fe-45e6-420f-b292-93d90af2c0cb 61 fields · synced May 18, 2026