Identity
- Trade Name
- evercare Gauze bandage Fix 5 cm x 10 m EUDAMED
- Device Name
- Fixation Bandages, non-sterile, non-elastic EUDAMED
- Model / Reference
- 3905-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129321753 EUDAMED
- Basic UDI-DI
- 6438129B0006H6 EUDAMED
- EMDN Code
- M030101 HYDROPHILIC GAUZE BANDAGES 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 Gauze bandage Fix 5 cm x 10 m 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 | 6438129B0006H6 | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED b8d17860-6e34-4c23-8cc8-3e18e98da667 61 fields · synced Jul 29, 2026