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nun

EUDAMED

Class I (EU MDR)

Ref 08800065600007Model WFE-02SRef 08800065600014Model WFC-01

by WikiOptics Inc.

Identity

Trade Name
nun EUDAMED
nun+ EUDAMED
Device Name
Ophthalmoscope EUDAMED
Fundus Camera EUDAMED
Model / Reference
WFE-02S EUDAMED
08800065600007 EUDAMED
WFC-01 EUDAMED
08800065600014 EUDAMED

Identifiers

Primary DI / UDI-DI
08800065600007 EUDAMED
08800065600014 EUDAMED
Basic UDI-DI
08800065600007H6 EUDAMED
8800065600014XH EUDAMED
EMDN Code
Z12120114 OPHTHALMOSCOPES EUDAMED
Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Poland EUDAMED
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

nun by WikiOptics 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

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Manufacturer

Manufacturer
WikiOptics Inc.
EUDAMED SRN
KR-MF-000026369
Authorised Representative
JaviTech e.K. DE-AR-000005875

Sources (2)

  • EUDAMED 96ba846a-44dc-4749-a8bf-0248b9356e10 61 fields · synced Jul 12, 2026
  • EUDAMED 98cde18e-cf35-4be5-afd8-c22b727b0d25 61 fields · synced May 19, 2026