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Medical Face Masks Type IIR/ Level 3 Ear-Loop
EUDAMEDClass I (EU MDR)
Ref 2288MON
Identity
- Trade Name
- Medical Face Masks Type IIR/ Level 3 Ear-Loop EUDAMED
- Device Name
- Face Masks EUDAMED
- Model / Reference
- 2288MON EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1252288MON2 EUDAMED
- Basic UDI-DI
- ++D125FACEMASKLG EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Medical Face Masks Type IIR/ Level 3 Ear-Loop by Premium Plus (Dongguan) Limited — 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 | ++D125FACEMASKLG | Class I | Active |
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Manufacturer
- Manufacturer
- Premium Plus (Dongguan) Limited
- EUDAMED SRN
- CN-MF-000038259
- Authorised Representative
- Premium Plus Poland sp. z o.o. PL-AR-000030110
Sources (1)
- EUDAMED e961696b-300d-4c44-8b04-3fed7cc8e44d 61 fields · synced Jun 20, 2026