Data / Medical devices / Taiwan / Bioteque Corp.
Bioteque Corp.: FDA-registered device maker in Taipei, Taiwan, 6 510(k) clearances
Bioteque Corp. is registered with the FDA (registration 3012480535) in Taipei, Taiwan. It lists 12 device types. The FDA files 6 510(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
- 3012480535
- Address
- 5F-6, No.23, Sec.1, Chang-An E. Rd., Taipei, Taiwan, 104
- Owner or operator
- BIOTEQUE CORP (9038266)
- Roles
- Exporter to the US
- 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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Nephrostomy | LJE | U | Exporter to the US | accessdata.fda.gov |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | 1 | Exporter to the US | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Exporter to the US | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Exporter to the US | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Exporter to the US | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Exporter to the US | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Exporter to the US | accessdata.fda.gov |
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Exporter to the US | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 | Exporter to the US | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Exporter to the US | accessdata.fda.gov |
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 |
| August 27, 2024 | K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | FBK | Substantially Equivalent | Laborie Medical Technologies, Corp. | 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 |
| July 21, 2009 | K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | FBK | Substantially Equivalent | Laborie Medical Technologies, Ltd. | accessdata.fda.gov |
| June 5, 1997 | K963064 | ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM | FFX | Substantially Equivalent | Laborie Medical Tech Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Cystometric, Hydraulic
- All makers of Tubing/Tubing With Filter, Insufflation, Laparoscopic
- All makers of Device, Intravascular Catheter Securement
- All makers of Tube, Smoke Removal, Endoscopic
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Laparoscopic Accessories, Gynecologic
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.