Planmed Sophie Classic
by Planmed Oy
Planmed Sophie Classic is a Class II device made by Planmed Oy, listed in FDA GUDID since 7 Sep 2016 (UDI-DI 06430035430055), not in commercial distribution (GUDID) as of 22 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 | Number06430035430055 | Date7 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 06430035430055
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Planmed
- Generic name
- Stationary mammographic x-ray system, analogue
- Model / reference
- Sophie Classic
- Primary DI / UDI-DI
- 06430035430055
- FDA product code
- IZH
- GMDN term
- Stationary mammographic x-ray system, analogue
- Device class
- Class II
- Regulation number
- 892.1710
- GUDID distribution status
- Not in Commercial Distribution
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