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Fetal Aneuploidies (Trisomy 21, Trisomy18 and Trisomy13) Detection Kit
EUDAMEDClass A (EU MDR)
Ref 160 tests/kit
Identity
- Device Name
- Fetal Aneuploidies (Trisomy 21, Trisomy18 and Trisomy13) Detection Kit EUDAMED
- Model / Reference
- 160 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974776970000 EUDAMED
- Basic UDI-DI
- 697477697FAL01RS EUDAMED
- EMDN Code
- W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Fetal Aneuploidies (Trisomy 21, Trisomy18 and Trisomy13) Detection Kit by CapitalBio Genomics Co., Ltd. — Class A — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697477697FAL01RS | Class A | Active |
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Manufacturer
- Manufacturer
- CapitalBio Genomics Co., Ltd.
- EUDAMED SRN
- CN-MF-000027716
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 31259ae8-a465-49d2-bb87-21d03abce32a 61 fields · synced Jun 18, 2026