Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008111569

FEI Number

3008111569

Entity Name

BOR JYE ENTERPRISE CO., LTD.

City/State/Country

Tainan, TW

Establishment Address

No. 36, Ln. 482, Sec. 1, Benyuan St., Annan District, Tainan 70954, TW

Establishment Type(s)

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

Owner / Operator

Bor Jye Enterprise Co., Ltd. (Owner Number: 10031027)

Owner / Operator Contact Address

No. 36, Ln. 482, Sec. 1, Benyuan St., Annan District, Tainan, TW-TNN 70954, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2009-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Bor Jye Enterprise Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008111569. Last updated year: 2026. Please use registration number 3008111569 when referencing this establishment in official correspondence.