Identity
- Trade Name
- SELEFA® Flat gauze sponges, 5-pack, sterile EUDAMED
- Device Name
- Sponges Gauze, sterile EUDAMED
- Model / Reference
- 222252 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129154252 EUDAMED
- Basic UDI-DI
- 6438129B0018HD EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I 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
Category: Intranasal splint, non-biodegradable
SELEFA® Flat gauze sponges, 5-pack, sterile by OneMed Group Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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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 | 6438129B0018HD | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED 074e0e21-31b4-47d2-a70b-fa3450ab1aa0 61 fields · synced Jul 21, 2026