Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035451914

FEI Number

3035451914

Entity Name

Bioteque Corporation Yilan Science Park Factory

City/State/Country

Yilan City, TW

Establishment Address

No.360, Yike Road, Hsinchu Science Park, Yilan City 260011, TW

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BIOTEQUE CORP (Owner Number: 9038266)

Owner / Operator Contact Address

5F-6, NO.23, SEC.1, CHANG-AN E. ROAD, TAIPEI, TW-TPE 104, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2015-11-24
HKS	Prism, Gonioscopic	Ophthalmic	Class 1	886.1660	2014-11-04
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	2014-11-04
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2011-07-23
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2021-12-20
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2021-12-20
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2012-02-21
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2011-07-23
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-04-17
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	Class 2	886.1385	2015-03-11
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2011-07-23
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2011-04-15
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-12-26
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2025-12-26
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2025-12-26
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2010-12-28
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2011-07-23
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2018-07-27

Official Correspondent

WILLIAM LEE

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

BIOTEQUE CORP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012480535	BIOTEQUE CORP.	Taipei, TW
3004207966	Bioteque Corporation I-Lan Factory II	Su-Ao Cheng Yilan, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K902734	Olympus Corp.	PR CANNULAS	1990-08-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035451914. Last updated year: 2026. Please use registration number 3035451914 when referencing this establishment in official correspondence.