FDA Device Establishments · JSON-LD · Markdown

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FEI 3030089857 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active

FEI Number3030089857
Owner / OperatorAuditdata A/S (#10032598)
Addressstr. Ziemniaczana 15, Wroclaw Dolnoslaskie, 52-127, PL
Mandatory US AgentAuditdata LLC
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)ETW
Regulation § (21 CFR)874.3310
Proprietary namesHIT - Measure by Otometrics; OTOPro; Primus Hearing instrument test unit - PHITU; 2000 Primus HIT Pro; HIT Unit; Unity 3 HIT Unit; Measure by Otometrics - HIT; 2005-1 HIT Unit

External sources

Source: openFDA. Public-domain (CC0).