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T020401

by Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş. EUDAMED

Active European Union

Ref OIM(SMS)-0402-052XLModel OIM(SMS)-0402

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86836284OIM(SMS)0402KK Basic UDI-DIDate26 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Disposable Surgical Overall-Type 3/4
Model / Reference
OIM(SMS)-0402, OIM(SMS)-0402-052XL
Primary DI / UDI-DI
08683628400500
Basic UDI-DI
86836284OIM(SMS)0402KK
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
TR-MF-000021222

Other devices from Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş.

See all devices from Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş. →

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