Vive SUP3008PNK
Part of a family of 17 devices: see the family page
Ref SUP3008LPNK
Vive SUP3008PNK is a Class I device made by Vive Health LLC, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 081832302SPLINTHANDA9) and listed in FDA GUDID since 3 Jun 2026 (UDI-DI 00810226440043), active as of 7 Nov 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 | Number081832302SPLINTHANDA9 00810226440043 | Date30 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00810226440043 | Date3 Jun 2026 | StatusListed |
Official records
- EUDAMED public site 081832302SPLINTHANDA9
- AccessGUDID record 00810226440043
Across registries
- EUDAMED Basic UDI-DI 081832302SPLINTHANDA9 registered 30 Oct 2026 Active
- FDA GUDID UDI-DI 00810226440043 listed 3 Jun 2026 Listed
Timeline
- Listed FDA GUDID 00810226440043
- Registered EUDAMED 081832302SPLINTHANDA9
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Vive
- Generic name
- Hand/finger splint, reusable
- Device name
- Finger Splint
- Model / reference
- SUP3008LPNK EUDAMEDSUP3008PNK GUDID
- Primary DI / UDI-DI
- 00810226440043
- Basic UDI-DI
- 081832302SPLINTHANDA9
- FDA product code
- ILH
- EMDN code
- Y060603 Fingers orthoses
- GMDN term
- Hand/finger splint, reusable
- Device class
- Class I
- Regulation number
- 890.3475
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | SUP3008LPNK | SUP3008PNK |
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