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Optima

by Centra for medical supplies 120 variants

Ref 110214

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 Number622300784GownHE Basic UDI-DI Date6 Jul 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
surgical gown Family
Model / Reference
110214
Primary DI / UDI-DI
06223007844246, 06223007844123, 06223007844055, 06223007843539, 06223007844093, 06223007842464, 06223007842457, 06223007842822, 06223007843058, 06223007843560, 06223007844062, 02622300784831
Basic UDI-DI
622300784GownHE
EMDN Code
T020402 Reinforced surgical gowns
Device Class
Class I

Manufacturer details

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

Properties

  • Sterile

Other properties (12)

  • 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