# FA-Tech Diagnostics Europe BV

FEI: 3011631044
Status: Active
Establishment types: Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner/operator: Epredia Holdings Ltd. (#10062642)

Address: 't Holland 31, Duiven Gelderland, 6921 GX, NL

Mandatory US Agent: new erie scientific llc

## Products

Total registered: 1
Top product codes: IDZ
Regulation §: 864.3010

Proprietary names: Laser biopsy cassettes in stripped stacks (orange) 25x40 with front lid, Laser biopsy cassettes in stripped stacks (green) 25x40 with front lid, Bionet cassettes in stripped stacks (blue) 25x40 with front lid, Laser embedding cassettes in stripped stacks (aqua) 45x40 with integrated lid, Laser embedding cassettes in stripped stacks (blue) 45x40 without lid (require metal lid), Bionet cassettes in stripped stacks (red) 25x40 with front lid, Laser embedding cassettes in stripped stacks (grey) 25x40 with front lid, Laser biopsy cassettes in stripped stacks (pink) 25x40 with front lid, Laser embedding cassettes in stripped stacks (green) 25x40 with hinged lid, Laser embedding cassettes in stripped stacks (lilac) 25x40 with hinged lid

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223011631044%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3011631044