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Hand set

by Pharmaplast

Ref PD21

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 Number62220238PharmaDrapeGN Basic UDI-DI 06222023883338UDI-DIDate4 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-065 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  • Withdrawn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
Surgical Drapes
Model / Reference
PD21
Primary DI / UDI-DI
06222023883338
Basic UDI-DI
62220238PharmaDrapeGN
EMDN Code
T020102 Specialistic surgery drapes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

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

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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