Identity
- Trade Name
- Andago EUDAMEDFDA UDI
- Generic Name
- Mobile gait rehabilitation system, harness-support FDA UDI
- Device Name
- Andago V2.0 EUDAMED
- Model / Reference
- 31585 EUDAMEDV2.0 FDA UDI
Identifiers
- Catalog Number
- 31585 FDA UDI
- Primary DI / UDI-DI
- 07640174660230 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017466ANUM EUDAMED
- FDA Product Code
- BXB FDA UDI
- EMDN Code
- N010299 NEUROLOGIC PHYSIOTHERAPHY DEVICES - OTHER EUDAMED
- GMDN Term
- Mobile gait rehabilitation system, harness-support FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5380 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Andago by Hocoma Ag — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764017466ANUM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hocoma AG
- EUDAMED SRN
- CH-MF-000014672
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4bb88a53-b994-4870-897e-8330da9c22b1 61 fields · synced Jul 17, 2026
- FDA UDI f3040203-6df6-4a12-b87d-94dc416a01d2 33 fields · synced May 27, 2026