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Royal Excellence

by Intigena GmbH & Co.KG. 2 variants

Ref 04013209000609, 04013209000623Model Inkontinenz-Einlagen

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, self-declared

Class I: no certifier involved

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 Number0401320900001FL Basic UDI-DI Date3 Dec 2021RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Inkontinenz-Einlagen, 04013209000609, 04013209000623
Primary DI / UDI-DI
04013209000609, 04013209000623
Basic UDI-DI
0401320900001FL
EMDN Code
T99 Protective devices and aids for incontinence (excluding personal protective equipment - PPE) - other
Device Class
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000004948

Other devices from Intigena GmbH & Co.KG.

See all devices from Intigena GmbH & Co.KG. →

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