Identity
- Device Name
- PRIMED Mask (Medical, Type II , and IIR) EUDAMED
- Model / Reference
- PG4-1001E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391534520634 EUDAMED
- Basic UDI-DI
- 5391534520106PRCAN24NT EUDAMED
- Unit of Use DI
- 05391534520627 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 (Medical +2 more) 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 dec6a2a6-b37f-46a3-b2f2-69cea6f230f8 61 fields · synced Jun 18, 2026