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PRIMED Mask (Medical, Type II, and IIR)

by PRIMED Medical Products Inc. 19 variants

Ref PG4-2092E

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5391534520106PRCAN24NT Basic UDI-DI 05391534521860UDI-DIDate12 Aug 2025RegisteredStatusActive

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  • Withdrawn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
PRIMED Mask (Medical, Type II, and IIR)
Model / Reference
PG4-2092E
Primary DI / UDI-DI
05391534521860
Basic UDI-DI
5391534520106PRCAN24NT
Unit of Use DI
05391534521853
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CA-MF-000014307
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Primed Medical Products Inc.

See all devices from Primed Medical Products Inc. →

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