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Optima

by Centra for medical supplies EUDAMED

Withdrawn Not intended for the EU market

Ref 200201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number622300784MaskFY Basic UDI-DIDate6 Jul 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Mask Family
Model / Reference
200201
Primary DI / UDI-DI
06223007841801
Basic UDI-DI
622300784MaskFY
EMDN Code
T020699 Medical use face masks (excluding personal protective equipment - PPE) - other
Device Class
Class I

Manufacturer details

EUDAMED SRN
EG-MF-000032710
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties

Show 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