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Fetal Chromosome Aneuploidy Analysis Software
EUDAMEDClass IVD General (EU MDR)
Ref I000003Model NIPT_analysis
Identity
- Trade Name
- Fetal Chromosome Aneuploidy Analysis Software EUDAMED
- Device Name
- Fetal Chromosome Aneuploidy Analysis Software EUDAMED
- Model / Reference
- NIPT_analysis EUDAMEDI000003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583254 EUDAMED
- Basic UDI-DI
- B-06974968583254 EUDAMED
- EMDN Code
- W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Fetal Chromosome Aneuploidy Analysis Software by GeneMind Biosciences Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06974968583254 | 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 (1)
- EUDAMED d2fb964a-f0ea-4bc7-aa2f-5b930dffcb88 61 fields · synced Jun 19, 2026