Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006899020

FEI Number

3006899020

Entity Name

HUAIAN HENING MEDICAL INSTRUMENTS CO ., LTD and its Subsidiary HUAIAN JUNRAN IMP.&EXP. TRADING CO.,LTD

City/State/Country

Huaian Jiangsu, CN

Establishment Address

NO.6 West Hongdou Road Economic Development Zone, Huaian Jiangsu 223005, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HOME AIDE DIAGNOSTICS, INC. (Owner Number: 9087599)

Owner / Operator Contact Address

1072 S. Powerline Rd., --, Deerfield Bch, FL 33442, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pro Comfor Lancets Easy Comfort Lancets True Comfort Lancets Pure Comfort Lancets True Comfort Pro Lancets Easy Comfort Lancets True Comfort Pro Pro Comfor Lancets True Comfort Lancets Pro Comfort Alcohol prep pads True Comfort Alcohol Prep Pads True Comfort Pro Alcohol Prep Pads

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	2023-02-03
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-02-03
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2013-10-30
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2015-01-26

Official Correspondent

AMGAD GIRGIS

US Agent Details

Amgad Girgis Email: amgad@homeaide.us Phone: (954) 7940221

Related Public Records

Same Entity

HOME AIDE DIAGNOSTICS, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005750815	HOME AIDE DIAGNOSTICS, INC.	Deerfield Bch, FL, US

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 3006899020. Last updated year: 2026. Please use registration number 3006899020 when referencing this establishment in official correspondence.