Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015112437

FEI Number

3015112437

Entity Name

TAIZHOU XINKE OPTICAL GLASSES CO.,LTD.

City/State/Country

Taizhou Zhejiang, CN

Establishment Address

Fuyang Village, Duqiao Town, Linhai City, Taizhou Zhejiang 317015, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

TAIZHOU XINKE OPTICAL GLASSES CO.,LTD. (Owner Number: 10059928)

Owner / Operator Contact Address

Fuyang Village, Duqiao Town, Linhai City, Taizhou, CN-ZJ 317015, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Optical Frame goggles SUNGLASSES Lens; Reading Glasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2019-03-10
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-01
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2019-03-10
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2019-03-10

Official Correspondent

XIXI PAN

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

TAIZHOU XINKE OPTICAL GLASSES 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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06

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3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015112437. Last updated year: 2026. Please use registration number 3015112437 when referencing this establishment in official correspondence.