FDA.report

Bioteque Taiwan Ltd.

Matched from indexed company URL: Bioteque Corporation

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30039680493003968049Bioteque Taiwan Ltd.1N2026-01-017F., No. 431,433, Baozhang Rd. Xizhi Dist., New Taipei City TW 221036
30124805353012480535BIOTEQUE CORP.1N2026-01-015F-6, No.23, Sec.1, Chang-An E. Rd. Taipei TW 104
30248606903024860690BIOTEQUE AMERICA, INC.1Y2026-01-011302 Exchange Drive, Suite # 150 Richardson TX US 75081
30354519143035451914Bioteque Corporation Yilan Science Park Factory1N2026-01-01No.360, Yike Road, Hsinchu Science Park Yilan City TW 260011
30038524361000121341BIOTEQUE AMERICA, INC.1Y2020-04-252051 Junction Ave. suite#128 San Jose CA US 95131

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
185121873859771K963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARMFFX1997-06-05
185121548480537K954341URODYNAMICS TUBING AND INFUSION SETSFEN1995-10-17
185121352272919K953451UROPUMP TUBE & DAMPING CHAMGERFEN1995-10-05
185121780872628K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE2025-12-22
3357621780872628K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE2025-12-22
185121531963478K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK2024-08-27
185121728395192K210419BIOTEQ Drainage Catheter BT-PDS-seriesFGE2022-04-13
3357621728395192K210419BIOTEQ Drainage Catheter BT-PDS-seriesFGE2022-04-13
3357621410015024K200103BIOTEQ Drainage Catheter Set (One Step Type)FGE2020-10-09
185121410015024K200103BIOTEQ Drainage Catheter Set (One Step Type)FGE2020-10-09
3200262029965953K173351Panpac Flexi Shelf PessaryHHW2018-10-31
185121213736529K152308Sensor Medical Single Use Tonometer PrismHKY2015-10-13
3357621963286316K142715Sensor Medical Family of Vitrectomy Lenses and ProductsHJK2014-12-16
185121963286316K142715Sensor Medical Family of Vitrectomy Lenses and ProductsHJK2014-12-16
3357621912363163K140368FAMILY OF DISPOSABLE LENSESHKS2014-04-29
185121912363163K140368FAMILY OF DISPOSABLE LENSESHKS2014-04-29
3200261522046478K132670PANPAC INFLATABLE DOCUT PESSARYHHW2014-06-04
3200261846044609K130273PANPAC VAGINAL DILATORSHDX2013-08-08
3200261085098574K130087PANPAC WORD/BARTHOLIN CATHETERKNA2014-01-10
3200261308950862K102898BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONELKF2011-12-15
185121621110187K102633BIOTEQ ANGIOGRAPHIC CATHETERDQO2011-09-09
3200261892827633K092984PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0LKF2010-04-07
3200261217156705K092983PANPAC HSG CATHETER SETLKF2010-06-07
3200261956965169K092982THE PANPAC SUCTION CURETTEHHK2010-07-26
3200261124517325K092981PANPAC VAGINAL PESSARYHHW2010-07-22
3200261873209562K092980PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5LKF2010-03-11
185121706196297K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPFBK2009-07-21
3218121986906531K041094HSG CATHETER SETLKF2004-06-17
185121609244633K033862BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCKFGE2005-02-14
185121737400031K033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SETFAD2004-12-30
185121663879713K031500EXCEL PRIMARY SOLUTION SETFPA2003-07-25
3218121958591772K020628CURELLE, PREFERRED CURELLE, CUTEQ 2.5HHK2002-05-24
3218121895346191K013289BIOTEQUE VAGINAL PESSARIESHHW2001-12-27
185121453377228K012526BIOTEQUE SCALP VEIN SETFPA2001-09-14
3218121418035393K003380BIOTEQUE VAGINAL DILATORHDX2001-01-29
185121639676493K002449BIOTEQ I.V. (INTRAVENOUS) SETFPA2000-12-22
185121409073581
185121856043699
185121982347466
185122016711036
185122065275083
185121111971071
3357621111971071
3357621196488290
185121196488290
3200261325426639
185121363365636
3357621363365636
3357621409073581
3357621531963478
3218121658841240
3357621706196297
3218121711735681
3200261724519073
185121740348404
3357621740348404
3357621856043699
185121873312104
3357621873312104
3357621873859771
3200261940338870
3357622013889872
185122013889872

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
FGE72025-12-22
LKF52011-12-15
HHW42018-10-31
FPA32003-07-25
FBK22024-08-27
HJK22014-12-16
HKS22014-04-29
HDX22013-08-08
HHK22010-07-26
FEN21995-10-17
HKY12015-10-13
KNA12014-01-10
DQO12011-09-09
FAD12004-12-30
FFX11997-06-05

PMN

GUDID

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