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PRIMED Mask (Other Accessories)

EUDAMED

Class I (EU MDR)

Ref PG4-5033ERef PG4-5073ERef PG4-1573E

by PRIMED Medical Products Inc.

Identity

Device Name
PRIMED Mask (Other Accessories) EUDAMED
Model / Reference
PG4-5033E EUDAMED
PG4-5073E EUDAMED
PG4-1573E EUDAMED

Identifiers

Primary DI / UDI-DI
05391534523031 EUDAMED
05391534523062 EUDAMED
05391534521532 EUDAMED
Basic UDI-DI
5391534520107PRCAN24PE EUDAMED
Unit of Use DI
05391534523024 EUDAMED
05391534523055 EUDAMED
05391534521525 EUDAMED
EMDN Code
T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

PRIMED Mask (Other Accessories) by Primed Medical Products Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
PRIMED Medical Products Inc.
EUDAMED SRN
CA-MF-000014307
Authorised Representative
mdi Europa GmbH DE-AR-000006218

Sources (3)

  • EUDAMED d272fc98-bcba-4c96-a7f8-dd50acb1117e 61 fields · synced Jul 15, 2026
  • EUDAMED c55032a9-59e7-431e-bfb7-950cf3fa1852 61 fields · synced May 16, 2026
  • EUDAMED 971e8302-070e-414c-85f9-1f3a4dc49903 61 fields · synced May 17, 2026