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Frenzel Goggles S5

by Daiichi Medical Co., Ltd. EUDAMED

Active European Union

Ref S5-4582368

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4582368093994S5W7 Basic UDI-DIDate24 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Frenzel Goggles
Model / Reference
S5-4582368
Primary DI / UDI-DI
04582368093994
Basic UDI-DI
4582368093994S5W7
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
JP-MF-000034518
Authorised representative
mdi Europa GmbH DE-AR-000006218

Properties

Other properties (13)

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