Bioteque Corp.
US Last updated 23 May 2026
- Devices
- 14
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Bioteq I.V. (Intravenous) Set Ref K002449
Bioteque A.V. Fistula Needle Set Ref K993118
Sheath Introducer Ref K150932
Bioteque Hemodialysis Blood Tubing Set Ref K992930
BIOTEQ Drainage Catheter BT-PDS-series Ref K210419
Bioteque 3 In 1 Hemodialysis Blood Tubing Pack Ref K013634
Bioteque Scalp Vein Set Ref K012526
Bioteq Double Pigtail Ureteral Stent Set Ref K033210
Bioteq Angiographic Catheter Ref K102633
BIOTEQ Drainage Catheter Set (One Step Type) Ref K200103
Curelle Ref K915491
FDA establishments
- Bioteque Corp. Taipei · TW FEI 3012480535
What Bioteque Corp. makes
Bioteque Corp. manufactures intravenous sets, hemodialysis blood tubing sets and packs, scalp vein sets, angiographic catheters, sheath introducers, pigtail drainage catheter sets, ureteral stent sets, and arteriovenous fistula needle sets with and without safety features.
The devices are classified as Class II and are listed in the FDA 510(k) registry; the company is based in the United States.
Frequently asked questions
What does Bioteque Corp. make?
Bioteque Corp. manufactures intravenous sets, hemodialysis blood tubing sets and packs, scalp vein sets, angiographic catheters, sheath introducers, pigtail drainage catheter sets, ureteral stent sets, and arteriovenous fistula needle sets with and without safety features. These products are designed for vascular access, fluid delivery, and drainage in clinical settings such as dialysis and angiography procedures.
Where is Bioteque Corp. based?
Bioteque Corp. is based in the United States, as indicated in the country field of the device data. The company operates within the U.S. regulatory framework, and its devices are listed in U.S. regulatory registries, which aligns with its country of origin.
Which regulatory registries list Bioteque Corp.'s devices?
Bioteque Corp.'s devices are listed in the FDA 510(k) registry, as specified in the LISTED IN field. This registry contains information about medical devices that have received clearance through the 510(k) premarket notification process, demonstrating substantial equivalence to a legally marketed predicate device.
How are Bioteque Corp.'s devices classified?
Bioteque Corp.'s devices are classified as Class II, as stated in the DEVICE CLASSES field. Class II devices are subject to special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, and specific labeling requirements, and typically require a 510(k) submission for market authorization in the United States.
Information
- Country
- US