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by PEGAVISION Corporation 2 variants

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Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471410212211209020N9 Basic UDI-DI Date25 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
38% Polymacon Color Frequent Replacement Soft Contact Lenses
58% Etafilcon A Color Daily Disposable Soft Contact Lenses
50% Toufilcon B Daily Disposable Soft Contact Lenses
Model / Reference
More
Primary DI / UDI-DI
4714102125283800301B3K, 4714102125245800301BZS, 4714102125140010317BSS, 4714102125284100301BYC, 4714102125246000301BW5, 4714102125246100301BWN, 4714102125283900301B44
Basic UDI-DI
471410212211209020N9, 471410212211209003N9, 471410212211209004NB
EMDN Code
Q0210040102, Q021004010101
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
TW-MF-000018739
Authorised representative
PEGATRON Czech s.r.o. CZ-AR-000002395

Other devices from Pegavision Corporation

See all devices from Pegavision Corporation →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No