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Rouška S Adh. Pruhem a Olep. Otvorem Pe

by MEDICA FILTER spol. s r.o.

Ref n4301-05A-OA2Model Rouška s krajovou adhezí a adhezním otvorem

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 Number8592333NDRAPE00001BF Basic UDI-DI 08592333065204UDI-DIDate29 May 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Operační Roušky Nesterilní
Model / Reference
Rouška s krajovou adhezí a adhezním otvorem, n4301-05A-OA2
Primary DI / UDI-DI
08592333065204
Basic UDI-DI
8592333NDRAPE00001BF
EMDN Code
T020102 Specialistic surgery drapes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CZ-MF-000018854

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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