Identity
- Trade Name
- Workstation Endotics Serie 4 EUDAMED
- Device Name
- Sistema Endoscopico Diagnostico EUDAMED
- Model / Reference
- ENDWS4-TC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053614400027 EUDAMED
- Basic UDI-DI
- 805361440SISENDOCOLON82 EUDAMED
- Direct Marketing DI
- 08053614400027 EUDAMED
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER 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
Workstation Endotics Serie 4 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 dcc534f4-4b3e-461b-b3a2-77bb07441f39 61 fields · synced Jul 21, 2026