Identity
- Trade Name
- Embryo Predict EUDAMED
- Device Name
- Embryo Predict EUDAMED
- Model / Reference
- 200-00201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860008987204 EUDAMED
- Basic UDI-DI
- 08600089872HERARB EUDAMED
- EMDN Code
- Z12080292 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
Embryo Predict by Alife Health Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250781 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08600089872HERARB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alife Health Inc.
- EUDAMED SRN
- US-MF-000028240
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 1d30313d-8840-4ea9-b101-c2b82e2e2522 61 fields · synced Jul 9, 2026
- FDA 510(k) K250781 1 fields · synced May 29, 2026