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53607c097-Pki

EUDAMED

Class I (EU MDR)

Ref 53607C097-PKIModel 536.07

by Univet Srl

Identity

Model / Reference
536.07 EUDAMED
53607C097-PKI EUDAMED

Identifiers

Primary DI / UDI-DI
08057147044925 EUDAMED
Basic UDI-DI
8057147COR012QE 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

53607c097-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

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Manufacturer

Manufacturer
Univet Srl
EUDAMED SRN
IT-MF-000030077

Sources (1)

  • EUDAMED 44a481de-e6d6-40f6-bd32-070646d38076 61 fields · synced Jul 10, 2026