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HOYA Corporation PENTAX Lifecare Division

FEI 3008185830 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active

FEI Number3008185830
Owner / OperatorHOYA Corporation PENTAX Division (#8030235)
AddressTsutsujigaoka 1-1-110, Akishima-shi Tokyo, 196-0012, JP
Mandatory US AgentHOYA CORPORATION PENTAX DIVISION
Registration expiry2026
Initial importer flagN
Registered products2
Product codes (top 20)FDF, FDS
Regulation § (21 CFR)876.1500
Proprietary namesPENTAX Medical Video Upper GI Scopes (EG29-i10); PENTAX Medical Video Upper GI Scopes (EG-3890TK); PENTAX Medical Video Upper GI Scopes (EG27-i10); PENTAX Medical Video Colonoscopes (EC-3890TLK); PENTAX Medical Video Upper GI Scopes (EG-2990i); PENTAX Medical Video Colonoscopes (EC34-i10L); PENTAX Medical Video Colonoscopes (EC-3890Li); PENTAX Medical Video Upper GI Scopes (EG-2490K); PENTAX Medical Video Colonoscopes (EC-2990Li); PENTAX Medical Video Colonoscopes (EC38-i10L)

External sources

Source: openFDA. Public-domain (CC0).