Identity
- Trade Name
- ArmeoSenso EUDAMEDArmeo FDA UDI
- Generic Name
- Biomechanical function analysis/rehabilitation software FDA UDI
- Device Name
- ArmeoSenso EUDAMED
- Model / Reference
- 32711 EUDAMEDArmeoSenso FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640174660285 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017466AXV9 EUDAMED
- Direct Marketing DI
- 07640174660285 EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- N01028099 NEUROLOGICAL PHYSIOTHERAPY DEVICES - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Biomechanical function analysis/rehabilitation software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
ArmeoSenso by Hocoma Ag — Class I — 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 | 764017466AXV9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hocoma AG
- EUDAMED SRN
- CH-MF-000014672
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0c362a65-b159-4b61-a997-ee3e6b74a82e 61 fields · synced Aug 3, 2026
- FDA UDI b04631e9-9d09-4db4-b78e-4895b8680f74 33 fields · synced May 30, 2026