Identity
- Trade Name
- Evercare® Comfort IV dressing, 10 x 12 cm EUDAMED
- Device Name
- Adhesive Surgical Film Dressings, sterile EUDAMED
- Model / Reference
- 4741 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129124361 EUDAMED
- Basic UDI-DI
- 6438129B0032H7 EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
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® Comfort IV dressing, 10 x 12 cm by OneMed Group Oy — Class IIa — 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 | 6438129B0032H7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (2)
- EUDAMED ee8c0497-b771-447b-9f1e-6747b1672237 61 fields · synced Jul 19, 2026
- EUDAMED 4ac7da46-8d96-4814-8c18-d141217b7fc0 61 fields · synced Jul 19, 2026