FDA.reportPublic FDA data

Bioteque Corporation Yilan Science Park Factory

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30354519143035451914Bioteque Corporation Yilan Science Park Factory1N2026-01-01No.360, Yike Road, Hsinchu Science Park Yilan City TW 260011

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3357621780872628K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE2025-12-22
3357621728395192K210419BIOTEQ Drainage Catheter BT-PDS-seriesFGE2022-04-13
3357621410015024K200103BIOTEQ Drainage Catheter Set (One Step Type)FGE2020-10-09
3357621963286316K142715Sensor Medical Family of Vitrectomy Lenses and ProductsHJK2014-12-16
3357621912363163K140368FAMILY OF DISPOSABLE LENSESHKS2014-04-29
3357621111971071
3357621196488290
3357621363365636
3357621409073581
3357621531963478
3357621706196297
3357621740348404
3357621856043699
3357621873312104
3357621873859771
3357622013889872

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGE32025-12-22
HJK12014-12-16
HKS12014-04-29