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Sterile Surgical Gowns

by Opti̇mal Sağlik Ürün. San. Ve Diş Ti̇c. Ltd. Şti̇.

Ref OSG0101004

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8699243OSGQE Basic UDI-DI 08699243180031UDI-DIDate27 Mar 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  • Withdrawn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
Sterile Surgical Gowns
Model / Reference
OSG0101004
Primary DI / UDI-DI
08699243180031
Basic UDI-DI
8699243OSGQE
EMDN Code
T020499 Surgical gowns - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000021855

Other devices from Opti̇mal Sağlik Ürün. San. Ve Diş Ti̇c. Ltd. Şti̇.

See all devices from Opti̇mal Sağlik Ürün. San. Ve Diş Ti̇c. Ltd. Şti̇. →

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