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10% Low Contrast (on both sides) Near Vision Card with 40cm (16in.) Cord.

EUDAMED

Class I (EU MDR)

Ref 2118

by Precision Vision, Inc.

Identity

Trade Name
10% Low Contrast (on both sides) Near Vision Card with 40cm (16in.) Cord. EUDAMED
Device Name
Vision Testing Chart EUDAMED
Model / Reference
2118 EUDAMED

Identifiers

Primary DI / UDI-DI
00811286032100 EUDAMED
Basic UDI-DI
081128603PVChartsLF EUDAMED
Direct Marketing DI
00811286032100 EUDAMED
EMDN Code
Z1212012099 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

10% Low Contrast (on both sides) Near Vision Card with 40cm (16in.) Cord. by Precision Vision, Inc. — Class I — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000008456
Authorised Representative
QNET B.V. NL-AR-000002695

Sources (1)

  • EUDAMED c7b772b1-958e-485c-9a77-7ca35a623682 61 fields · synced Jul 9, 2026