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Double-Happy Low Contrast Test

EUDAMED

Class I (EU MDR)

Ref 2012-6

by Precision Vision, Inc.

Identity

Trade Name
Double-Happy Low Contrast Test EUDAMED
Device Name
Vision Testing Chart EUDAMED
Model / Reference
2012-6 EUDAMED

Identifiers

Primary DI / UDI-DI
00811286031721 EUDAMED
Basic UDI-DI
081128603PVChartsLF EUDAMED
Direct Marketing DI
00811286031721 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

Double-Happy Low Contrast Test by Precision Vision, 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

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

Sources (1)

  • EUDAMED 219c8887-a15d-463e-a0b8-5beb30f4b0f7 61 fields · synced Jul 30, 2026