Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008381116

FEI Number

3008381116

Entity Name

SHANGHAI GAOHUI RUBBER AND PLASTIC PRODUCTS CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

No. 6 Lane 381 Hongan Rd., Zhujingzhen, Jinshan District, Shanghai 201503, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

SHANGHAI GAOHUI RUBBER AND PLASTIC PRODUCTS CO., LTD (Owner Number: 10032286)

Owner / Operator Contact Address

#6 Lane 381 Hongan Rd., Zhujingzhen, Jinshan District, Shanghai, CN-SH 201503, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

1" WideX36" Long-White Strap Hook&Loop Strap dvt sleeve Calf thigh DVT Pressure Infuser Tourniquet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2024-11-08
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-07-10
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2018-12-21
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2024-03-28

Official Correspondent

Richard Gao

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

SHANGHAI GAOHUI RUBBER AND PLASTIC PRODUCTS CO., LTD

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008381116. Last updated year: 2026. Please use registration number 3008381116 when referencing this establishment in official correspondence.