Identity
- Trade Name
- Embra® Optimia Nonwoven swabs 10 x 10 cm EUDAMED
- Device Name
- Swabs Nonwoven, folded, non-sterile EUDAMED
- Model / Reference
- 22300303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129370232 EUDAMED
- Basic UDI-DI
- 6438129B0011GX EUDAMED
- EMDN Code
- M0202030102 NON-WOVEN 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
Embra® Optimia Nonwoven swabs 10 x 10 cm 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 | 6438129B0011GX | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED 5f63c932-06a8-41c2-ac39-16bf29a67f58 61 fields · synced Jul 14, 2026