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Medical Face Masks Type IIR/ Level 3 Ear-Loop
EUDAMEDClass I (EU MDR)
Ref 2288LRef 2288BKRef 2288PRef 2288L3Ref 2288L4Ref 2288F4Ref 2288F2Ref 2288F3
Identity
- Trade Name
- Medical Face Masks Type IIR/ Level 3 Ear-Loop EUDAMED
- Device Name
- Face Masks EUDAMED
- Model / Reference
- 2288L EUDAMED2288BK EUDAMED2288P EUDAMED2288L3 EUDAMED2288L4 EUDAMED2288F4 EUDAMED2288F2 EUDAMED2288F3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1252288L2 EUDAMED+D1252288BK2 EUDAMED+D1252288P2 EUDAMED+D1252288L32 EUDAMED+D1252288L42 EUDAMED+D1252288F42 EUDAMED+D1252288F22 EUDAMED+D1252288F32 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 (8)
- EUDAMED 6eed24c0-7139-44ea-9ea2-5f31292fc4ad 61 fields · synced Aug 5, 2026
- EUDAMED d7c30ec7-d31e-49c7-97bd-a43bbc6ee899 61 fields · synced May 11, 2026
- EUDAMED b8954286-f7ed-4657-a247-af97a11544d2 61 fields · synced May 16, 2026
- EUDAMED e586d982-dc42-46e1-bf8d-14b9cffff001 61 fields · synced May 17, 2026
- EUDAMED a5855966-eb0a-4191-91f3-0fc909e99eab 61 fields · synced May 17, 2026
- EUDAMED 1f1fcaa6-51d4-48be-b72c-248581f52fc3 61 fields · synced May 17, 2026
- EUDAMED fe85edb9-4701-4d6e-b313-5fb570710a8b 61 fields · synced May 18, 2026
- EUDAMED 077005f9-b44e-4081-9f99-bf6286341ea7 61 fields · synced May 18, 2026