Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009544661

FEI Number

3009544661

Entity Name

Dongguan SafeSecure Plastics Co., Ltd.

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

Room 102, 402 and 502, building 2, No.6 of Zhao Lin Jinchuan 4th road, Xiegang Town, Dongguan City Guangdong 523601, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Specimen Transport Bag; Biohazard Bag Equipment Cover Product Ice Wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2016-08-15
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2016-08-15
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2011-11-20
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2019-04-10
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2016-01-31

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
3007539307	Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd	Shenzhen 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009544661. Last updated year: 2026. Please use registration number 3009544661 when referencing this establishment in official correspondence.