Identity
- Trade Name
- ArmeoPower EUDAMEDArmeo FDA UDI
- Generic Name
- Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
- Device Name
- ArmeoPower EUDAMED
- Model / Reference
- 30806 EUDAMEDPower FDA UDI
Identifiers
- Catalog Number
- 30806 FDA UDI
- Primary DI / UDI-DI
- 07640174660193 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017466APUR EUDAMED
- Direct Marketing DI
- 07640174660193 EUDAMED
- FDA Product Code
- IKK FDA UDIION FDA UDI
- EMDN Code
- N01028099 NEUROLOGICAL PHYSIOTHERAPY DEVICES - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI890.5370 FDA UDI
- Market of Registration
- Netherlands 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
ArmeoPower 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 | 764017466APUR | 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 3cf74e5f-98ec-439f-bee2-be6f15e318bc 61 fields · synced Jul 20, 2026
- FDA UDI b5268611-cccf-4f2b-975a-d1e3598e8cee 33 fields · synced May 30, 2026