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Non-mydriatic Fundus Camera

EUDAMED

Class IIa (EU MDR)

Ref TFC-1000Model NFC-700Ref PolarisRef RetinaStation

by Crystalvue Medical Corporation

Identity

Trade Name
Non-mydriatic Fundus Camera EUDAMED
Device Name
Infrared Fundus Camera EUDAMED
Model / Reference
NFC-700 EUDAMED
TFC-1000 EUDAMED
Polaris EUDAMED
RetinaStation EUDAMED

Identifiers

Primary DI / UDI-DI
04719876420107 EUDAMED
04719876420282 EUDAMED
04719876420015 EUDAMED
04719876420077 EUDAMED
Basic UDI-DI
471987642FUNDUSCAMERAYG EUDAMED
EMDN Code
Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED
Finland EUDAMED
France 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

Non-mydriatic Fundus Camera by Crystalvue Medical Corporation — Class IIa — 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
Crystalvue Medical Corporation
EUDAMED SRN
TW-MF-000018351
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (4)

  • EUDAMED 9e7aec05-23d2-48e1-a85e-e19810513a3f 61 fields · synced Jul 29, 2026
  • EUDAMED 5f7e0941-abc1-49bb-85b8-38c51fa00a63 61 fields · synced May 17, 2026
  • EUDAMED 2f6f72f4-169b-4c7e-92aa-455fdbe71869 61 fields · synced May 18, 2026
  • EUDAMED 400187db-5799-4526-8c76-2efa08ea1916 61 fields · synced Jul 12, 2026