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PRIMED Mask (Medical +2 more)
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 (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 (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