Identity
- Trade Name
- Omnifol EUDAMED
- Model / Reference
- STERILIZATION ROLLS EUDAMED20410593 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E307204105931 EUDAMED
- Basic UDI-DI
- ++E307STERROLLH3 EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Omnifol by Euronda S.p.a. — 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 | ++E307STERROLLH3 | Class I | Active |
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Manufacturer
- Manufacturer
- Euronda S.p.a.
- EUDAMED SRN
- IT-MF-000007762
Sources (1)
- EUDAMED b1316a78-1e1b-4c27-bea2-5b218c41b51d 61 fields · synced Jun 19, 2026