Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006619672

FEI Number

3006619672

Entity Name

HORNG TZER MEDICAL INSTRUMENTS, LTD.

City/State/Country

KAOHSIUNG, TW

Establishment Address

7F-1, NO.286-3, XINYA RD., CIANJHEN DISTRICT, KAOHSIUNG 80673, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HORNG TZER MEDICAL INSTRUMENTS, LTD. (Owner Number: 9094959)

Owner / Operator Contact Address

7F-1, NO.286-3, HSIN YA RD., CHIEN CHEN DISTRICT, KAOHSIUNG, TW-NOTA 700, 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
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2012-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Stan Yang Business: Unicare Biomedical, Inc. Email: syunicare@gmail.com Phone: (949) 3051770

Related Public Records

Same Entity

HORNG TZER MEDICAL INSTRUMENTS, 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 3006619672. Last updated year: 2026. Please use registration number 3006619672 when referencing this establishment in official correspondence.