Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035858922

FEI Number

3035858922

Entity Name

DONGGUAN MEDJOINT BIOTECH CO., LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 101, Building 16, No.136, Gangjian Road, Changping Town, Dongguan Guangdong 523000, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Dongguan Medjoint Biotech Co., Ltd. (Owner Number: 10092494)

Owner / Operator Contact Address

Room 101, Building 16, No.136, Gangjian Road, Changping Town, Dongguan, CN-GD 523000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pressure Connecting Tube High Pressure Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-01-14
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-01-14

Official Correspondent

Shasha Zhang

US Agent Details

Terry Lan Business: Maiwei Inc. Email: Terry.lan@maiweibio.com Phone: (503) 8219531

Related Public Records

Same Entity

Dongguan Medjoint Biotech 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-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035858922. Last updated year: 2026. Please use registration number 3035858922 when referencing this establishment in official correspondence.