# Demant Operations Poland Sp. z o.o.

FEI: 3009307953
Status: Active
Establishment types: Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner/operator: DEMANT A/S (#8010048)

Address: ul. Lubieszynska 59, Mierzyn Zachodniopomorskie, 72-006, PL

Mandatory US Agent: Oticon Inc.

## Products

Total registered: 1
Top product codes: MAH
Regulation §: 874.3302

Proprietary names: Ponto BHX Implant, 3 mm, with abutment, 9 mm, Soft healing cap, Ponto BHX Implant, 4 mm, with abutment, 12 mm, Ponto BHX Implant, 4 mm, Ponto BHX Implant, 4 mm, with abutment, 14 mm, Ponto BHX Implant, 4 mm, with abutment, 6 mm, Double-ended dissector, MIPS Back-up kit, 3 mm, Ponto BHX Implant, 3 mm, with abutment, 6 mm, Ponto BHX Implant, 4 mm, with abutment, 9 mm

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223009307953%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3009307953