optibike basic 196001
optibike basic 196001 is a Class II device made by ergoline GmbH, listed in FDA GUDID since 12 May 2023 (UDI-DI 04059358002224), 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 | Number04059358002224 | Date12 May 2023 | StatusListed |
Official records
- AccessGUDID record 04059358002224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- optibike basic
- Generic name
- Bicycle ergometer
- Model / reference
- 196001
- Primary DI / UDI-DI
- 04059358002224
- FDA product code
- ISD
- GMDN term
- Bicycle ergometer
- Device class
- Class II
- Regulation number
- 890.5360
- GUDID distribution status
- In Commercial Distribution
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