Identity
- Device Name
- Univfy PreIVF Report EUDAMED
- Model / Reference
- UPR-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262456840005 EUDAMED
- Basic UDI-DI
- 426245684preivfMJ EUDAMED
- Direct Marketing DI
- 04262456840005 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES 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
Univfy PreIVF Report by Univfy Inc. — Class IIa — 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 | 426245684preivfMJ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Univfy Inc.
- EUDAMED SRN
- US-MF-000046344
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED 35bbd221-a340-4d6d-ab54-d622575c0c8a 61 fields · synced Jul 26, 2026