Identity
- Device Name
- PRIMED Mask (Medical, Type II , and IIR) EUDAMED
- Model / Reference
- PG4-2073E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391534521808 EUDAMED
- Basic UDI-DI
- 5391534520106PRCAN24NT EUDAMED
- Unit of Use DI
- 05391534521792 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 - Type II by Primed Medical Products Inc. — Class I — MDR — listed in EUDAMED — 3 models — 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 | 5391534520106PRCAN24NT | Class I | Active |
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Manufacturer
- Manufacturer
- PRIMED Medical Products Inc.
- EUDAMED SRN
- CA-MF-000014307
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED d4d97a82-453d-4ed3-b190-99d3fc992e46 61 fields · synced Jun 18, 2026