Identity
- Trade Name
- evercare Surgical mask, white EUDAMED
- Device Name
- Surgical Face Mask Antifog, non-sterile EUDAMED
- Model / Reference
- 2876 EUDAMED2853 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129115642 EUDAMED06438129115628 EUDAMED
- Basic UDI-DI
- 6438129B0046HJ EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
evercare Surgical mask, white by OneMed Group Oy — 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 | 6438129B0046HJ | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (2)
- EUDAMED 99b2607a-7d41-4dae-8c3b-bd1493f6ee47 61 fields · synced Jul 30, 2026
- EUDAMED f7c6ac75-18f3-44c8-a3ee-d068b650d3a0 61 fields · synced May 18, 2026