ArmeoSpring Pro
by Hocoma AG
Ref 61958
ArmeoSpring Pro (61958) is a virtual-display rehabilitation system (EU MDR Class I; FDA Class II) made by Hocoma AG, registered in EUDAMED on 22 Feb 2023 (Basic UDI-DI 764017466AOUP) and listed in FDA GUDID since 11 Oct 2023 (UDI-DI 07640174660353), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07640174660353 | Date11 Oct 2023 | StatusListed |
| European Union | CE/MDR EUDAMED | Number764017466AOUP 07640174660353 | Date22 Feb 2023 | StatusActive |
Official records
- EUDAMED public site 764017466AOUP
- AccessGUDID record 07640174660353
Across registries
- EUDAMED Basic UDI-DI 764017466AOUP registered 22 Feb 2023 Active
- FDA GUDID UDI-DI 07640174660353 listed 11 Oct 2023 Listed
Timeline
- Registered EUDAMED 764017466AOUP
- Listed FDA GUDID 07640174660353
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- ArmeoSpring Pro EUDAMEDArmeo GUDID
- Generic name
- Virtual-display rehabilitation system, powered-support, upper-limb
- Device name
- ArmeoSpring
- Model / Ref / Catalog
- 61958, Spring Pro
- Primary DI / UDI-DI
- 07640174660353
- Basic UDI-DI
- 764017466AOUP
- Direct marketing DI
- 07640174660353
- FDA product code
- IKK, ION
- EMDN code
- N01028099 Neurological physiotherapy devices - accessories - other
- GMDN term
- Virtual-display rehabilitation system, powered-support, upper-limb
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 890.1925, 890.5370
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 61958 | Spring Pro |
| Device class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- CH-MF-000014672
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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