Identity
- Trade Name
- SMARTIBD EUDAMED
- Device Name
- SMARTIBD - AI software for the analysis of endoscopic video images EUDAMED
- Model / Reference
- SMARTIBD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15065010840031 EUDAMED
- Basic UDI-DI
- 5065010840OD04PF EUDAMED
- EMDN Code
- G99 GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Smartibd by Odin Medical Limited — 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 | 5065010840OD04PF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Odin Medical Limited
- EUDAMED SRN
- GB-MF-000026653
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED f84b9282-d6f0-43ad-bc25-21be339f311b 61 fields · synced Jun 18, 2026