Identity
- Trade Name
- Indego Mobile App EUDAMED
- Device Name
- Indego Mobile App EUDAMEDIndego Mobile App (Accessory) EUDAMED
- Model / Reference
- 212-006-XXX EUDAMED
Identifiers
- Primary DI / UDI-DI
- NotApplicable EUDAMEDN/A EUDAMED
- Basic UDI-DI
- ++B168INDEGOMOBILEAPP47 EUDAMED++M704INDEGOMOBILEAPPLY EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - 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
Indego Mobile App by Ekso Bionics, Inc. — 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 | ++B168INDEGOMOBILEAPP47 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ekso Bionics, Inc.
- EUDAMED SRN
- US-MF-000024649
- Authorised Representative
- QAdvis EAR AB SE-AR-000001599
Sources (2)
- EUDAMED 6f9cef7f-1fa7-4a97-89fa-11f129f91f6a 61 fields · synced Jul 9, 2026
- EUDAMED bd93bc1a-73ef-4ff9-83e8-7f196788ebf4 61 fields · synced May 17, 2026