BIOTEQUE CORP.

Matched from indexed company URL: Bioteque-Corp

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3012480535	3012480535	BIOTEQUE CORP.	1	N	2026-01-01	5F-6, No.23, Sec.1, Chang-An E. Rd. Taipei TW 104
3035451914	3035451914	Bioteque Corporation Yilan Science Park Factory	1	N	2026-01-01	No.360, Yike Road, Hsinchu Science Park Yilan City TW 260011

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
18512	1873859771	K963064	ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM	FFX	1997-06-05
18512	1548480537	K954341	URODYNAMICS TUBING AND INFUSION SETS	FEN	1995-10-17
18512	1352272919	K953451	UROPUMP TUBE & DAMPING CHAMGER	FEN	1995-10-05
18512	1780872628	K251019	BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G	FGE	2025-12-22
335762	1780872628	K251019	BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G	FGE	2025-12-22
18512	1531963478	K241523	injeTAK Adjustable Tip Needle (DIS199; DIS201)	FBK	2024-08-27
335762	1728395192	K210419	BIOTEQ Drainage Catheter BT-PDS-series	FGE	2022-04-13
18512	1728395192	K210419	BIOTEQ Drainage Catheter BT-PDS-series	FGE	2022-04-13
18512	1410015024	K200103	BIOTEQ Drainage Catheter Set (One Step Type)	FGE	2020-10-09
335762	1410015024	K200103	BIOTEQ Drainage Catheter Set (One Step Type)	FGE	2020-10-09
18512	1213736529	K152308	Sensor Medical Single Use Tonometer Prism	HKY	2015-10-13
335762	1963286316	K142715	Sensor Medical Family of Vitrectomy Lenses and Products	HJK	2014-12-16
18512	1963286316	K142715	Sensor Medical Family of Vitrectomy Lenses and Products	HJK	2014-12-16
18512	1912363163	K140368	FAMILY OF DISPOSABLE LENSES	HKS	2014-04-29
335762	1912363163	K140368	FAMILY OF DISPOSABLE LENSES	HKS	2014-04-29
18512	1621110187	K102633	BIOTEQ ANGIOGRAPHIC CATHETER	DQO	2011-09-09
18512	1706196297	K090830	LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP	FBK	2009-07-21
18512	1609244633	K033862	BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK	FGE	2005-02-14
18512	1737400031	K033210	BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET	FAD	2004-12-30
18512	1663879713	K031500	EXCEL PRIMARY SOLUTION SET	FPA	2003-07-25
18512	1453377228	K012526	BIOTEQUE SCALP VEIN SET	FPA	2001-09-14
18512	1639676493	K002449	BIOTEQ I.V. (INTRAVENOUS) SET	FPA	2000-12-22
18512	1409073581
18512	1856043699
18512	1982347466
18512	2016711036
18512	2065275083
18512	1111971071
335762	1111971071
335762	1196488290
18512	1196488290
335762	1363365636
18512	1363365636
335762	1409073581
335762	1531963478
335762	1706196297
18512	1740348404
335762	1740348404
335762	1856043699
335762	1873312104
18512	1873312104
335762	1873859771
335762	2013889872
18512	2013889872

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FGE	7	2025-12-22
FPA	3	2003-07-25
FBK	2	2024-08-27
HJK	2	2014-12-16
HKS	2	2014-04-29
FEN	2	1995-10-17
HKY	1	2015-10-13
DQO	1	2011-09-09
FAD	1	2004-12-30
FFX	1	1997-06-05

PMN#

BIOTEQ Drainage Catheter BT-PDS-series
2022-04-13
Bioteque Corporation
BIOTEQ Drainage Catheter Set (One Step Type)
2020-10-09
Bioteque Corporation
Sheath Introducer
2016-07-22
BIOTEQUE CORP.
BIOTEQ ANGIOGRAPHIC CATHETER
2011-09-09
BIOTEQUE CORP.
BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
2005-02-14
BIOTEQUE CORP.
BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
2004-12-30
BIOTEQUE CORP.
BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
2004-03-22
BIOTEQUE CORP.
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
2002-07-09
BIOTEQUE CORP.
BIOTEQUE SCALP VEIN SET
2001-09-14
BIOTEQUE CORP.
BIOTEQ I.V. (INTRAVENOUS) SET
2000-12-22
BIOTEQUE CORP.
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
2000-02-09
BIOTEQUE CORP.
BIOTEQUE A.V. FISTULA NEEDLE SET
1999-12-17
BIOTEQUE CORP.
CURELLE
1992-11-04
BIOTEQUE CORP.