Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012944064

FEI Number

3012944064

Entity Name

SHENZHEN HYS MEDICAL CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building 3, Huayisheng Industrial Park, Fenghuang Village, Fuyong Town, Bao'an District, Shenzhen Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shenzhen HuaYi Safety Medical Technology co., Ltd. (Owner Number: 10052396)

Owner / Operator Contact Address

Hua Yi Sheng Ind. Park, #4 Industrial Zo, Fenhuang Village, Shenzhen, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BIO-SAV BONE MILL, DISPOSABLE PREFEREX DELIVERY SYSTEM, DISPOSABLE URI CAP FEMALE DEVICE Comfort First Speculum

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2018-08-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-12-20
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2021-12-20
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2025-01-02

Official Correspondent

No official correspondent registered.

US Agent Details

James Scott Hay Business: JB Medical Development, LLC (d/b/a MD3, LLC) Email: shay@md3inc.com Phone: (877) 6036333

Related Public Records

Same Entity

Shenzhen HuaYi Safety Medical 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3005809810	Jarit GmbH	Rietheim-Weilheim Baden-Wurttemberg, DE
1625507	MEDTRONIC POWERED SURGICAL SOLUTIONS	FORT WORTH, TX, US
2246990	J & J INSTRUMENTS, LLC	Stratford, CT, US
1061927	INTERNATIONAL STERILIZATION LABORATORY, LLC	GROVELAND, FL, US
1834331	PARAGON MEDICAL, INC.	PIERCETON, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012944064. Last updated year: 2026. Please use registration number 3012944064 when referencing this establishment in official correspondence.