Identity
- Model / Reference
- 555 EUDAMED555P00097-PKI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057147045809 EUDAMED
- Basic UDI-DI
- 8057147COR015QL EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
555p00097-Pki by Univet Srl — 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 | 8057147COR015QL | Class I | Active |
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Manufacturer
- Manufacturer
- Univet Srl
- EUDAMED SRN
- IT-MF-000030077
Sources (1)
- EUDAMED 23b11c42-253f-434c-b964-206192e23ced 61 fields · synced Jul 14, 2026