Identity
- Trade Name
- SELEFA®Optimia Flat gauze sponges 8x8 mm EUDAMED
- Device Name
- Sponges Gauze, non-sterile EUDAMED
- Model / Reference
- 222051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129354232 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
SELEFA®Optimia Flat gauze sponges 8x8 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED 3049f13c-ef24-46ba-a1ab-8bd3fafccb48 61 fields · synced Jul 23, 2026