FDA Device Establishments · JSON-LD · Markdown

Oticon Medical AB

FEI 3007367732 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active

FEI Number3007367732
Owner / OperatorDEMANT A/S (#8010048)
AddressDatavagen 37B, Askim Vastra Gotaland, 43632, SE
Mandatory US AgentOTICON MEDICAL, LLC
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)MAH
Regulation § (21 CFR)874.3302
Proprietary namesWide implant, 4 mm, with Abutment, 14 mm; Abutment, 14 mm; Ruler

External sources

Source: openFDA. Public-domain (CC0).