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Surgical gowns

by DINA – HITEX, spol. s r.o. 39 variants

Ref 354553-SModel Standard surgical gowns, Reinforced surgical gowns

Active European Union

CE MDR

Valid until

10 Nov 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

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 Number8591527000200ISPN Basic UDI-DI 08591527172841UDI-DIDate3 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2023-MDR/QS-049 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Nov 2023
    Expires
    10 Nov 2028

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Standard surgical gowns, Reinforced surgical gowns, 354553-S
Primary DI / UDI-DI
08591527172841
Basic UDI-DI
8591527000200ISPN
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000000312

Other devices from DINA – HITEX, spol. s r.o.

See all devices from DINA – HITEX, spol. s r.o. →

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