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PRIMED Mask - Type II
EUDAMEDClass I (EU MDR)
Ref PG4-4331ERef PG4-4073ERef PG4-311ERef PG4-2001ERef PG4-1680ERef PG4-1073ERef PG4-2492ERef PG4-2092E
Identity
- Device Name
- PRIMED Mask (Medical, Type II , and IIR) EUDAMED
- Model / Reference
- PG4-4331E EUDAMEDPG4-4073E EUDAMEDPG4-311E EUDAMEDPG4-2001E EUDAMEDPG4-1680E EUDAMEDPG4-1073E EUDAMEDPG4-2492E EUDAMEDPG4-2092E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391534522850 EUDAMED05391534522799 EUDAMED05391534523932 EUDAMED05391534521747 EUDAMED05391534521228 EUDAMED05391534520726 EUDAMED05391534522225 EUDAMED05391534521860 EUDAMED
- Basic UDI-DI
- 5391534520106PRCAN24NT EUDAMED
- Unit of Use DI
- 05391534522843 EUDAMED05391534522782 EUDAMED05391534523925 EUDAMED05391534521730 EUDAMED05391534521211 EUDAMED05391534520719 EUDAMED05391534522218 EUDAMED05391534521853 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 (8)
- EUDAMED 1ada2fa1-2dc0-46f9-a0b5-f7ec56076222 61 fields · synced Aug 3, 2026
- EUDAMED b792c520-c07c-479e-8b92-95cd304c8f25 61 fields · synced May 16, 2026
- EUDAMED 1d15330e-60bd-451d-a4ee-ebbfd8ea5e21 61 fields · synced May 17, 2026
- EUDAMED 3f0d659f-a3c4-404c-9bdf-83b2b3c9750f 61 fields · synced May 18, 2026
- EUDAMED d3e224e3-9b0d-466b-8cf5-3187f99b0b2b 61 fields · synced May 18, 2026
- EUDAMED 5d5898c1-7cc8-4bf5-b296-bb2100317653 61 fields · synced May 18, 2026
- EUDAMED 7adebbbd-83a4-4227-95f2-14b1cefb7faf 61 fields · synced May 18, 2026
- EUDAMED ae65e21d-bdd5-4f44-a1bd-0e632b367c8d 61 fields · synced May 18, 2026