Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017230778

FEI Number

3017230778

Entity Name

DONGGUAN SAFESECURE MEDICAL PACKAGING CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No 52, Zhenxing Road, Xiegang,Xiegang Town, Dongguan Guangdong 523601, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dongguan SafeSecure Medical Packaging Co., Ltd (Owner Number: 10073704)

Owner / Operator Contact Address

No 52, Zhenxing Road, Xiegang,Xiegang Town, Dongguan, CN-GD 523601, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterilization Pouches / Sterilization Rolls WRAP,STERILIZATION Sterilization Pouches / Sterilization Rolls Wrap,sterilization Sterilization Pouches / Sterilization Rolls

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2020-06-10
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2020-06-10
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2020-06-10
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2020-06-10
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-12-16
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-12-16

Official Correspondent

Parker Lee

US Agent Details

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

Related Public Records

Same Entity

Dongguan SafeSecure Medical Packaging Co., Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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 3017230778. Last updated year: 2026. Please use registration number 3017230778 when referencing this establishment in official correspondence.