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Sms Sterile Gown

by Zerkaya Teksti̇l Medi̇kal Gida İnşaat İth. İhr. San. Ve Ti̇c. Ltd. Şti̇.

Ref ZRK-03

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number868391107ZRK-03QU Basic UDI-DI 08683911070069UDI-DIDate19 Feb 2025RegisteredStatusActive

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  • Withdrawn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
Sms Gown
Model / Reference
ZRK-03
Primary DI / UDI-DI
08683911070069
Basic UDI-DI
868391107ZRK-03QU
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
TR-MF-000027572

From the manufacturer

Manufacturer's product page: SMS Gown

Other devices from Zerkaya Teksti̇l Medi̇kal Gida İnşaat İth. İhr. San. Ve 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