Identity
- Trade Name
- KIT monouso RoboClean EUDAMED
- Device Name
- Sistema Endoscopico Diagnostico EUDAMED
- Model / Reference
- ENDO-RBC-SU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053614400089 EUDAMED
- Basic UDI-DI
- 805361440SISENDOCOLON82 EUDAMED
- Direct Marketing DI
- 08053614400089 EUDAMED
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Endoscopic spray catheter, single-use
KIT monouso RoboClean by Era Endoscopy Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Endoscopic spray catheter, single-use.
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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 | 805361440SISENDOCOLON82 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Era Endoscopy Srl
- EUDAMED SRN
- IT-MF-000034111
Sources (1)
- EUDAMED a89b6b68-722c-4ce9-b4b2-0286a268fa78 61 fields · synced Jul 15, 2026