Skip to content

Covrel

by Fapomed- Dispositivos Médicos, S.A. EUDAMED

Active European Union

Ref 260-644Model Surgical Gown Standard

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number56009615SG0000146 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Surgical standard gown, L
Model / Reference
Surgical Gown Standard, 260-644
Primary DI / UDI-DI
05600961546132
Basic UDI-DI
56009615SG0000146
EMDN Code
T020402 Reinforced surgical gowns
Device Class
Class I
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
PT-MF-000004129

Other devices from Fapomed- Dispositivos Médicos, S.A.

See all devices from Fapomed- Dispositivos Médicos, S.A. →

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