FDA Device Establishments · JSON-LD · Markdown

Inission Syd AB (Malmo AB)

FEI 3013596041 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active

FEI Number3013596041
Owner / OperatorAuditdata A/S (#10032598)
AddressJaegersrovaegen 204, Malmo Skane, 21377, SE
Mandatory US AgentAuditdata LLC
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)EWO
Regulation § (21 CFR)874.1050
Proprietary names3000 Real Ear - BC1; 2000-1 Fitting Unit - Measure by Otometrics; SA1 RE-7 Headphone; BC1 Bone Conductor; CA1 HF Audiometric Headphone; 3000 Real Ear - IN1; 3000 Real Ear - CA1; 2000 Primus fitting unit Pro - PFU Pro; Entomed SA 202; 2000 Primus Ice

External sources

Source: openFDA. Public-domain (CC0).