Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021274187

FEI Number

3021274187

Entity Name

JIANXIN BIOMEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Luzhu District Kaohsiung, TW

Establishment Address

3F., No. 69, Luke 2nd Rd., Luzhu District Kaohsiung 821, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jianxin Biomedical Technology Co., Ltd. (Owner Number: 10083344)

Owner / Operator Contact Address

3F., No. 69, Luke 2nd Rd., Luzhu District, TW-KHH 821, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Jianxin Hydrogel Wound Dressing (Non-Sterile)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2021-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Feng-Yu Lee Business: Dynamic Biotech Inc. Email: fengyulee@ivddreg.com Phone: (949) 2180929

Related Public Records

Same Entity

Jianxin Biomedical Technology Co., Ltd.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021274187. Last updated year: 2026. Please use registration number 3021274187 when referencing this establishment in official correspondence.