Identity
- Device Name
- Endoscope-i Smartphone Adapter EUDAMED
- Model / Reference
- ei11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060774440117 EUDAMED
- Basic UDI-DI
- 506077444ESAGM EUDAMED
- Direct Marketing DI
- 05060774440117 EUDAMED
- EMDN Code
- Z12021080 ENT ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Endoscope-i Smartphone Adapter by Endoscope-i Ltd — 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 | 506077444ESAGM | Class I | Active |
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Manufacturer
- Manufacturer
- Endoscope-i Ltd
- EUDAMED SRN
- UK-MF-000044880
- Authorised Representative
- CERT3GLOBAL, UNIPESSOAL, LDA. PT-AR-000037982
Sources (1)
- EUDAMED 60cbae01-44ad-4893-be1e-1bfc7847431a 61 fields · synced Jun 18, 2026