Data / Medical devices / Taiwan / Bioteque Corporation I-Lan Factory II
Bioteque Corporation I-Lan Factory II: FDA-registered device maker in Su-Ao Cheng Yilan, Taiwan, 2 510(k) clearances
Bioteque Corporation I-Lan Factory II is registered with the FDA (registration 3004207966) in Su-Ao Cheng Yilan, Taiwan. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004207966
- Address
- No.5 Chung Cheng Rd., Su-Ao Cheng Yilan, Taiwan, 270
- Owner or operator
- BIOTEQUE CORP (9038266)
- Roles
- 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, TUB101: Tubing, Measurement;, TUB500: Tubing, Pump, Infusion line;
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | 1 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Contract manufacturer | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Manufacturer | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Lens, Condensing, Diagnostic | HJL | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Prism, Gonioscopic | HKS | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| 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 |
Compare with other makers
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Catheter, Nephrostomy, General & Plastic Surgery
- All makers of Lens, Contact, Polymethylmethacrylate, Diagnostic
- All makers of Device, Cystometric, Hydraulic
- All makers of Prism, Gonioscopic
- All makers of Lens, Condensing, Diagnostic
Updated April 13, 2022. 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.