← Back to catalogue
Preimplantation Genetic Testing For Aneuploidy Detection Kit（Reversible Termina…
EUDAMEDClass IVD General (EU MDR)
Ref L000032Model 96 tests/kit
Identity
- Trade Name
- Preimplantation Genetic Testing For Aneuploidy Detection Kit（Reversible Terminator Sequencing） EUDAMED
- Device Name
- Preimplantation Genetic Testing For Aneuploidy Detection Kit（Reversible Terminator Sequencing） EUDAMED
- Model / Reference
- 96 tests/kit EUDAMEDL000032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583124 EUDAMED
- Basic UDI-DI
- B-06974968583124 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（Reversible Termina… 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-06974968583124 | 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
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 32939f97-7b94-47e7-bde5-7303f94c9484 61 fields · synced Jun 18, 2026