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Protectfilm® Gentle

by Pharmaplast 31 variants

Ref PROTG6585

Active European Union

CE MDR

Valid until

24 Nov 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number62220238GentleDressingsVU Basic UDI-DI 06222023809079UDI-DIDate4 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-063 Active

    Quality assurance EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    24 Nov 2025
    Expires
    24 Nov 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Gentle Dressings
Model / Reference
PROTG6585
Primary DI / UDI-DI
06222023809079
Basic UDI-DI
62220238GentleDressingsVU
EMDN Code
M04010101, M04010102
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
EG-MF-000004501
Authorised representative
E C REP LIMITED IE-AR-000003995

Other devices from Pharmaplast

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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