Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026211706

FEI Number

3026211706

Entity Name

TIANJIN HUADA HONGYI BIOTECHNOLOGY CO., LTD.

City/State/Country

Tianjin, CN

Establishment Address

No. 50, Gaoying Road,National Independent Innovation Demonstration Zone, Beizhakou Town, Jinnan District, Tianjin 300350, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Tianjin Huada Hongyi Biotechnology Co., Ltd. (Owner Number: 10086735)

Owner / Operator Contact Address

No. 50, Gaoying Road,National Independent Innovation Demonstration Zone, Beizhakou Town, Jinnan District, Tianjin, CN-TJ 300350, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Twist-off Lancet lancet Heel Stick Safety lancet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-12-06
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-12-06
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-12-06

Official Correspondent

Zhendong Song

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

Tianjin Huada Hongyi Biotechnology 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
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026211706. Last updated year: 2026. Please use registration number 3026211706 when referencing this establishment in official correspondence.