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Basic Reinfoced Gown Small

by Arabian Medical Products Manufacturing Company (Enayah)

Ref EN62820

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 Number6281141EN04UU Basic UDI-DI 62811410563760UDI-DIDate28 Apr 2024RegisteredStatusActive 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  • Withdrawn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
Sterile Surgical Gowns
Model / Reference
EN62820
Primary DI / UDI-DI
62811410563760
Basic UDI-DI
6281141EN04UU
Direct Marketing DI
62811410563760
EMDN Code
T020402 Reinforced surgical gowns
Device Class
Class I

Manufacturer details

EUDAMED SRN
SA-MF-000012228
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Arabian Medical Products Manufacturing Company (Enayah)

See all devices from Arabian Medical Products Manufacturing Company (Enayah) →

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