Data / Medical devices / Taiwan / Bioteque Corporation Yilan Science Park Factory
Bioteque Corporation Yilan Science Park Factory: FDA-registered device maker in Yilan City, Taiwan, 5 510(k) clearances
Bioteque Corporation Yilan Science Park Factory is registered with the FDA (registration 3035451914) in Yilan City, Taiwan. It lists 16 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035451914
- Address
- No.360, Yike Road, Hsinchu Science Park, Yilan City, Taiwan, 260011
- Owner or operator
- BIOTEQUE CORP (9038266)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- December 28, 2010
- Registered through
- 2026
- Brand names listed
- CATHETERS, SUCTION, TRACHEOBRONCHIAL, MEDCOMP BREEZE Biliary Drain with Locking Pigtail Set, MEDCOMP BREEZE Biliary Drain without Locking Pigtail Set, PACK, HOT OR COLD, DISPOSABLE, TUB101: Tubing, Measurement;, TUB500: Tubing, Pump, Infusion line;, TUBE, SMOKE REMOVAL, ENDOSCOPIC, Trocar Cleaning Swab and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2025 | K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | FGE | Substantially Equivalent | Bioteque Corporation | accessdata.fda.gov |
| April 13, 2022 | K210419 | BIOTEQ Drainage Catheter BT-PDS-series | FGE | Substantially Equivalent | Bioteque Corporation | accessdata.fda.gov |
| October 9, 2020 | K200103 | BIOTEQ Drainage Catheter Set (One Step Type) | FGE | Substantially Equivalent | Bioteque Corporation | accessdata.fda.gov |
| December 16, 2014 | K142715 | Sensor Medical Family of Vitrectomy Lenses and Products | HJK | Substantially Equivalent | Sensor Medical Technology, LLC | accessdata.fda.gov |
| April 29, 2014 | K140368 | FAMILY OF DISPOSABLE LENSES | HKS | Substantially Equivalent | Sensor Medical Technology, LLC | accessdata.fda.gov |
Compare with other makers
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Updated December 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.