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OP-Mantel, extrabreit

by Sengewald Klinikprodukte GmbH

Ref 464459Model 464428

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4034393C1STGOWNSPIR7M Basic UDI-DI 04034393317021UDI-DIDate24 Apr 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  • Withdrawn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
Or-Gown, 150 Cm, Xl, Tur, Sterile
Model / Reference
464428, 464459
Primary DI / UDI-DI
04034393317021
Basic UDI-DI
4034393C1STGOWNSPIR7M
EMDN Code
T020402 Reinforced surgical gowns
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000008734

Other devices from Sengewald Klinikprodukte GmbH

See all devices from Sengewald Klinikprodukte GmbH →

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