Scala Sla-Bx 20 01-N
by Spineart
Ref SLA-BX 20 01-N
Scala Sla-Bx 20 01-N is a Class I device made by Spineart, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 1764045086SRI02REUSIN012R) and listed in FDA GUDID since 24 Jul 2026 (UDI-DI 07640221370853), 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 |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07640221370853 | Date24 Jul 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number1764045086SRI02REUSIN012R 07640221370853 | Date23 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 1764045086SRI02REUSIN012R
- AccessGUDID record 07640221370853
Across registries
- EUDAMED Basic UDI-DI 1764045086SRI02REUSIN012R registered 23 Jun 2026 Active
- FDA GUDID UDI-DI 07640221370853 listed 24 Jul 2026 Listed
Timeline
- Registered EUDAMED 1764045086SRI02REUSIN012R
- Listed FDA GUDID 07640221370853
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Scala® Posterior Disc Prep Set - Middle Tray EUDAMEDScala GUDID
- Generic name
- Instrument tray, reusable
- Device name
- Reusable Instruments I Boxes
- Model / reference
- SLA-BX 20 01-N
- Primary DI / UDI-DI
- 07640221370853
- Basic UDI-DI
- 1764045086SRI02REUSIN012R
- Direct marketing DI
- 07640221370853
- FDA product code
- FSM
- EMDN code
- S010401 Trays, baskets, tubs for sterilisation and their components
- GMDN term
- Instrument tray, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- EU registration type
- Standard device
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Supplied sterile | Yes | No |