Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022528821

FEI Number

3022528821

Entity Name

J SUMMIT CO., LTD.

City/State/Country

Chomthong Krung Thep Maha Nakhon, TH

Establishment Address

62/39 Moo 1, Chomthong Krung Thep Maha Nakhon 10150, TH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

J Summit Co., Ltd. (Owner Number: 10085429)

Owner / Operator Contact Address

62/39 Moo 1, Chomthong, TH-NOTA 10150, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

For Hose Assemblies; Hose Assemblies and Hose Retractors Solida

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2022-06-16
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2022-06-16
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2022-06-16
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2023-04-04
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2023-04-04

Official Correspondent

Titiwut Vajiraviroj

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

J Summit 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-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

Similar Registrations

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3011919098	NINGBO JUST SOON INDUSTRIAL LIMITED	Ningbo Zhejiang, CN
3004264602	SHANGHAI FOREIGN TRADE ENTERPRISES PUDONG CO., LTD.	Shanghai, CN
1419185	Ohio Medical LLC	Gurnee, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022528821. Last updated year: 2026. Please use registration number 3022528821 when referencing this establishment in official correspondence.