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Medical Face Masks Type IIR/ Level 3 Tie-On
EUDAMEDClass I (EU MDR)
Ref 2288TLRef 2288TGRef 2288TWRef 2288TB
Identity
- Trade Name
- Medical Face Masks Type IIR/ Level 3 Tie-On EUDAMED
- Device Name
- Face Masks EUDAMED
- Model / Reference
- 2288TL EUDAMED2288TG EUDAMED2288TW EUDAMED2288TB EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1252288TL2 EUDAMED+D1252288TG2 EUDAMED+D1252288TW2 EUDAMED+D1252288TB2 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 Tie-On 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 (4)
- EUDAMED bfcfa6c7-1c42-4261-9836-a0a17790b926 61 fields · synced Jul 29, 2026
- EUDAMED 032ec65c-96bf-4822-b114-03887e702916 61 fields · synced May 18, 2026
- EUDAMED 7af8d3da-9eb6-4323-a8fa-af2365d962b9 61 fields · synced May 18, 2026
- EUDAMED 44548650-e0c7-4f27-a323-3b182acb60ac 61 fields · synced May 18, 2026