Bioteque Corporation I-Lan Factory II

FDA Device Registration & Listing · Su-Ao Cheng Yilan, TW · Registration 3004207966

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004207966
FEI Number
3004207966
Entity Name
Bioteque Corporation I-Lan Factory II
City/State/Country
Su-Ao Cheng Yilan, TW
Establishment Address
No.5 Chung Cheng Rd., Su-Ao Cheng Yilan 270, TW
Establishment Type(s)
Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

TUB500: Tubing, Pump, Infusion line; TUB101: Tubing, Measurement; MEDCOMP BREEZE Biliary Drain with Locking Pigtail Set MEDCOMP BREEZE Biliary Drain without Locking Pigtail Set

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
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2018-07-27
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2011-04-15
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic Ophthalmic Class 2 886.1385 2015-03-11
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2022-06-23
GBO Catheter, Nephrostomy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2022-06-23

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
3035451914 Bioteque Corporation Yilan Science Park Factory Yilan City, TW

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K902734 Olympus Corp. PR CANNULAS 1990-08-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0036-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. 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 3004207966. Last updated year: 2026. Please use registration number 3004207966 when referencing this establishment in official correspondence.
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