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4613.00

by Textil Planas Oliveras S.A.

Ref 4613.00Model Apósito quirúrgico de algodón hidrófilo

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 Number8428123COMP.GASAQUIR5P Basic UDI-DI 08428123102043UDI-DIDate27 Aug 2026RegisteredStatusActive 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  • Withdrawn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

Model / Reference
Apósito quirúrgico de algodón hidrófilo, 4613.00
Primary DI / UDI-DI
08428123102043
Basic UDI-DI
8428123COMP.GASAQUIR5P
EMDN Code
M0201020201 Cotton gauzes, folded, with x-ray detectable thread, sterile
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
ES-MF-000001830

Other devices from Textil Planas Oliveras S.A.

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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