Identity
- Trade Name
- SANEO EUDAMED
- Device Name
- COMPRESE STERILE TAIATE 8X10X50BUC EUDAMED
- Model / Reference
- CTDS16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944751000863 EUDAMED
- Basic UDI-DI
- B-05944751000863 EUDAMED
- EMDN Code
- M0201010101 COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Saneo by Sc Spd Star Srl — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05944751000863 | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Spd Star Srl
- EUDAMED SRN
- RO-MF-000004404
Sources (1)
- EUDAMED 3bcec702-44ef-49ca-a5c8-8326d65b1268 61 fields · synced Jun 19, 2026