Identity
- Trade Name
- Sonda Monouso Endotics EUDAMED
- Device Name
- Sistema Endoscopico Diagnostico EUDAMED
- Model / Reference
- EWSND-TC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053614400003 EUDAMED
- Basic UDI-DI
- 805361440SISENDOCOLON82 EUDAMED
- Direct Marketing DI
- 08053614400003 EUDAMED
- EMDN Code
- Z12020699 LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Sonda Monouso Endotics by Era Endoscopy Srl — Class IIa — 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 | 805361440SISENDOCOLON82 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Era Endoscopy Srl
- EUDAMED SRN
- IT-MF-000034111
Sources (1)
- EUDAMED daf7dd75-c982-4c0e-8893-adeb50a69c18 61 fields · synced Jul 9, 2026