Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009498536

FEI Number

3009498536

Entity Name

Tianjin Huahong Technology Co., Ltd.

City/State/Country

Tianjin, CN

Establishment Address

A01, Plant B, No 278, Hangkong Road,Tianjin Pilot Free Trade Zone (Air Port Industrial Park), Tianjin 300308, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tianjin Huahong Technology Co., Ltd. (Owner Number: 10038941)

Owner / Operator Contact Address

A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), Tianjin, CN-TJ 300308, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Huahong Huahong GLUCOPAD TC SMART +Lancets JJ Care Diska Nulife Lancing Device CareTouch Lancing Device Diska Nulife Single Use Lancets 30G Pylo Single Use Lancets 30G iHealth VivaGuard Lancing Device metene CareLiving CareTouch Lancet Greater Goods Single Use Lancets 30G Greater Goods Lancing Device Single Use Lancets 30G Lancing Device Pylo Lancing Device TeleRPM Single Use Lancets 30G TeleRPM Lancing Device VivaGuard Lancets PEN TIPS Dynarex MedtFine Medt Medt - Fine Insulin Pen Needle (Safety Type) Huahong MEDILET Huahong

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-04-02
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2024-10-22
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-06-30
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2026-02-13
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-06-23
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-07-07
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-07-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-11-15
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2025-02-08
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-11-19
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2024-11-19
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-11-19
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2024-09-20
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

QIAN LI Business: Carelife USA Inc. Email: li@carelifeusa.com Phone: (404) 4261248

Related Public Records

Same Entity

Tianjin Huahong Technology 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

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
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Similar Registrations

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3004468256	SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.	Suzhou City Jiangsu, CN
3010515547	PROMISEMED HANGZHOU MEDITECH CO.,LTD.	Hangzhou Zhejiang, CN
3012172036	TASSO INC	Seattle, WA, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009498536. Last updated year: 2026. Please use registration number 3009498536 when referencing this establishment in official correspondence.