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previoMedical Procedure gown, with elastic cuffs, non-woven, non-sterile

by ZARYS International Spółka z ograniczoną odpowiedzialnością 11 variants

Ref PM-FI2NG-XL

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59079968T0205-PMM5 Basic UDI-DI 05904109603573UDI-DIDate15 Jan 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  • Withdrawn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
non-sterile procedure gown
Model / Reference
PM-FI2NG-XL
Primary DI / UDI-DI
05904109603573
Basic UDI-DI
59079968T0205-PMM5
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000000410

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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