Identity
- Trade Name
- evercare Gauze round sponges, diam. 70 mm EUDAMED
- Device Name
- Sponges Gauze, non-sterile EUDAMED
- Model / Reference
- 222256 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129352306 EUDAMED
- Basic UDI-DI
- 6438129B0016H9 EUDAMED
- EMDN Code
- M0201050102 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE 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 round sponges, diam. 70 mm 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 | 6438129B0016H9 | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED fdd00fc2-471a-4e08-9727-83cef68a530c 61 fields · synced Jun 17, 2026