Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007539307

FEI Number

3007539307

Entity Name

Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd

City/State/Country

Shenzhen City Guangdong, CN

Establishment Address

903, Tower B, OCT Central One, Mintang Road, Longhua District, Shenzhen City Guangdong 518131, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. (Owner Number: 10038881)

Owner / Operator Contact Address

903, Tower B, OCT Central One, Mintang Road, Longhua District, Shenzhen city, CN-GD 518131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032065

PMA Number

N/A

All Registered Proprietary Names

Vis-U-All Low Temperature Sterilization Pouch/Tubing Safe Secure Sterilization Pouches and Rolls Procedure Mask Sterilization Pouch Sterilization Pouches / Sterilization Rolls Sterilization Pouches / Sterilization Rolls Protective Clothing Ice Wrap Equipment Cover Product

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2016-08-15
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2016-11-16
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-12-16
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-12-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-13
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-03-18
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2016-11-16
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2016-08-15
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2019-03-01
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-13
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2016-01-31
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2019-04-10

Official Correspondent

Patty Chen

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009544661	Dongguan SafeSecure Plastics Co., Ltd.	Dongguan City Guangdong, CN

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007539307. Last updated year: 2026. Please use registration number 3007539307 when referencing this establishment in official correspondence.