Identity
- Device Name
- PRIMED Mask (Other Accessories) EUDAMED
- Model / Reference
- PG4-5063E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391534521310 EUDAMED
- Basic UDI-DI
- 5391534520107PRCAN24PE EUDAMED
- Unit of Use DI
- 05391534521303 EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Iceland 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5391534520107PRCAN24PE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PRIMED Medical Products Inc.
- EUDAMED SRN
- CA-MF-000014307
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 2a42357e-2a6b-43e0-a29f-2410c284357a 61 fields · synced Jun 18, 2026