Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617489

FEI Number

3003598505

Entity Name

TAIWAN BIOTECH CO., LTD.

City/State/Country

TAOYUAN, TW

Establishment Address

22 CHIEH SHOU RD., TAOYUAN 330, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TAIWAN BIOTECH CO., LTD. (Owner Number: 9036218)

Owner / Operator Contact Address

22 CHIEH SHOU RD., --, TAOYUAN, TW-TAO 330, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110221

PMA Number

N/A

All Registered Proprietary Names

Eye-Cept Rewetting Drops LensGiene Sterile Saline Solution LensGiene

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2007-11-21
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-11-28
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2016-11-28
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2012-06-12

Official Correspondent

C.S. Yang

US Agent Details

PATRICIA CHIU Business: OPTICS LABORATORY, INC. Email: pchiu@opticslab.com Phone: (626) 3501926

Related Public Records

Same Entity

TAIWAN BIOTECH CO., 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
K093254	Abbott Medical Optics, Inc.	AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION	2010-09-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-05	Ciba Vision Corporation	2	SOLO-care Plus with Aqualube, Multi-purpose solution* AquaSoft (Private label), Multi-purpose solutionSterile**For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Z-0129-2011	Abbott Medical Optics Inc (AMO)	2	AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Z-0130-2011	Abbott Medical Optics Inc (AMO)	2	AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.
Z-0030-2022	Contamac Solutions, Inc.	2	Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

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1032500	Bausch & Lomb Incorporated	GREENVILLE, SC, US
3003093882	NIAGARA PHARMACEUTICALS, INC.	Dundas Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617489. Last updated year: 2026. Please use registration number 9617489 when referencing this establishment in official correspondence.