Tor 3 Violet Dusk 8946
by Leloi AB
Tor 3 Violet Dusk 8946 is a Class II device made by Leloi AB, listed in FDA GUDID since 26 Jun 2023 (UDI-DI 07350075028946), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07350075028946 | Date26 Jun 2023 | StatusListed |
Official records
- AccessGUDID record 07350075028946
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Tor 3 Violet Dusk
- Generic name
- Penile ring
- Model / reference
- 8946
- Primary DI / UDI-DI
- 07350075028946
- FDA product code
- LKY
- GMDN term
- Penile ring
- Device class
- Class II
- Regulation number
- 876.5020
- GUDID distribution status
- In Commercial Distribution
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