Bioteque Taiwan Ltd.

FDA Device Registration & Listing · Xizhi Dist., New Taipei City, TW · Registration 3003968049

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
3003968049
FEI Number
3003968049
Entity Name
Bioteque Taiwan Ltd.
City/State/Country
Xizhi Dist., New Taipei City, TW
Establishment Address
7F., No. 431,433, Baozhang Rd., Xizhi Dist., New Taipei City 221036, TW
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Bioteque Taiwan Ltd. (Owner Number: 10088630)
Owner / Operator Contact Address
7F, No. 431 and 7F, No. 433, Baozhang Rd., Xizhi Dist., New Taipei City, TW-NWT 221036, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K132670
PMA Number
N/A

All Registered Proprietary Names

The Curette and Preferred Curette Flexi Shelf Pessary Uterine Manipulator Injector 4.5 Uterine sound Uterine Injector 2/4 Vaginal Dilator HSG Catheter Set Bellota Sonohysterography Catheter Silicon Inflatable Donut Pessary

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2023-09-08
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2023-09-08
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2023-09-08
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2024-02-21
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2023-09-08
HDX Dilator, Vaginal Obstetrics/Gynecology Class 2 884.3900 2023-09-08
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2023-09-08
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2023-09-08
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2023-09-08

Official Correspondent

No official correspondent registered.

US Agent Details

Gary Liu Business: Bioteque Amercia Inc. Email: garyliu@bioteque.com Phone: (800) 8899008

Related Public Records

Same Entity

Bioteque Taiwan Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K933654 Johnson & Johnson Medical, Inc. BLADDER NECK SUPPORT PROTHESIS FITTING KIT 1995-05-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003968049. Last updated year: 2026. Please use registration number 3003968049 when referencing this establishment in official correspondence.
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