STANDY-4 large
by Ormesa SRL
Ref 23Model STANDY
STANDY-4 large is a Class I device made by Ormesa SRL, registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 805571570STANDYMD) and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 08055715705094), active as of 25 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 |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number805571570STANDYMD 08055715705094 | Date21 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08055715705094 | Date31 Jan 2025 | StatusListed |
Official records
- EUDAMED public site 805571570STANDYMD
- AccessGUDID record 08055715705094
Across registries
- EUDAMED Basic UDI-DI 805571570STANDYMD registered 21 Jul 2026 Active
- FDA GUDID UDI-DI 08055715705094 listed 31 Jan 2025 Listed
Timeline
- Listed FDA GUDID 08055715705094
- Registered EUDAMED 805571570STANDYMD
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- STANDY-4 large EUDAMEDStandy GUDID
- Generic name
- Manual stander
- Model / reference
- STANDY EUDAMED23 EUDAMEDSTANDY-4 large GUDID
- Primary DI / UDI-DI
- 08055715705094
- Basic UDI-DI
- 805571570STANDYMD
- FDA product code
- INM
- EMDN code
- Y050202 Standing frames
- GMDN term
- Manual stander
- Device class
- Class I
- Regulation number
- 890.3100
- EU registration type
- Standard device
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | STANDY 23 | STANDY-4 large |
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