FDA Registration
Active
🇹🇼 Taiwan
Bioteque Corporation Yilan Science Park Factory
Reg #: 3035451914
·
FEI: 3035451914
·
Expires 2026
Products
16
Proprietary Names
9
Establishment Types
4
Classifications
16
Registration Details
- Registration Name
- Bioteque Corporation Yilan Science Park Factory
- Registration Number
- 3035451914
- FEI Number
- 3035451914
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.360, Yike Road, Hsinchu Science Park
- City
- Yilan City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K140368
Owner / Operator
- Firm Name
- BIOTEQUE CORP
- Operator Number
- 9038266
- Address
- 5F-6, NO.23, SEC.1, CHANG-AN E. ROAD
- City
- TAIPEI
- State
- TW-TPE
- Postal Code
- 104
- Country
- TW
- Correspondent
- WILLIAM - LEE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2015-11-24 |
| Prism, Gonioscopic | HKS | Class 1 | Ophthalmic | No | 2014-11-04 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2014-11-04 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2011-07-23 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2021-12-20 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2021-12-20 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2012-02-21 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2011-07-23 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2015-03-11 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2011-07-23 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2011-04-15 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2025-12-26 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2010-12-28 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2011-07-23 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2018-07-27 |
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2026-04-17 |
Proprietary Names
PACK, HOT OR COLD, DISPOSABLE
Tubing/tubing with filter, insufflation, laparoscopic
Trocar Cleaning Swab
TUB500: Tubing, Pump, Infusion line;
TUB101: Tubing, Measurement;
CATHETERS, SUCTION, TRACHEOBRONCHIAL
TUBE, SMOKE REMOVAL, ENDOSCOPIC
MEDCOMP BREEZE Biliary Drain with Locking Pigtail Set
MEDCOMP BREEZE Biliary Drain without Locking Pigtail Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device