Identity
- Trade Name
- Vita Embryo EUDAMED
- Device Name
- Software for Decision Support Tool for The Prioritization of Embryos EUDAMED
- Model / Reference
- Vita Embryo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809970350007 EUDAMED
- Basic UDI-DI
- 880997035VITAEMBRYO86 EUDAMED
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vita Embryo by Kai Health, Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880997035VITAEMBRYO86 | Class I | Active |
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Manufacturer
- Manufacturer
- Kai Health, Inc
- EUDAMED SRN
- KR-MF-000037551
- Authorised Representative
- SOAR & PARTNERS Sp. z o.o. PL-AR-000040956
Sources (1)
- EUDAMED ee177da7-dbbe-4fc5-97b6-d71355385066 61 fields · synced Jun 19, 2026