Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009715914

FEI Number

3009715914

Entity Name

Shanghai PAX Medical Instrument Co., Ltd.

City/State/Country

Shanghai, CN

Establishment Address

Building 3, No. 438 Fulian Two Road, Baoshan District, Shanghai 201906, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai PAX Medical Instrument Co., Ltd. (Owner Number: 10056374)

Owner / Operator Contact Address

Building 3, No. 438 Fulian Two Road, Baoshan District, Shanghai, CN-SH 201906, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Minor LED Surgical Light: a) PML30 Series: PML30; PML30K; PML30K(Ceiling);PML30(Wall-mount);PML30(Mobile);PML30(Ceiling) Minor LED Surgical Light: b)PX350. PML30K (Wall-mount) ; PML30K(Mobile) Electric Examination Table Examination Light: a) ELD Series; ELD ; ELD10; ELD20; b) DK/L. Mechanical Operating Table ST Series: ST-A; ST-B; ST-C; ST-D. Orthopedic Extension Device: 1008; 1009 Carbon Fiber Orthopedic Device CF Series: CF280; CF290; CF380

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2017-12-04
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2022-01-11
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2017-12-04
FWX	Table, Operating-Room, Mechanical	General, Plastic Surgery	Class 1	878.4950	2017-12-04
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2022-01-11

Official Correspondent

Guo Li

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 5882250

Related Public Records

Same Entity

Shanghai PAX Medical Instrument Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009715914. Last updated year: 2026. Please use registration number 3009715914 when referencing this establishment in official correspondence.