Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037007193

FEI Number

3037007193

Entity Name

SHANGHAI HUIZHOU INDUSTRIAL CO., LTD

City/State/Country

Shanghai City District, CN

Establishment Address

No. 7030 East Yinggang Road, Shanghai City District 201706, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shanghai Huizhou Industrial Co., Ltd (Owner Number: 10092791)

Owner / Operator Contact Address

No. 7030 East Yinggang Road, Shanghai City District, CN-SH 201706, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tempk Therapy Packs Tempk Insulin Cooler Travel Case

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-02-19
OJL	Insulin Vial Protector/Holder	Physical Medicine	Class 1	890.5050	2025-03-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp. Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shanghai Huizhou Industrial Co., Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037007193. Last updated year: 2026. Please use registration number 3037007193 when referencing this establishment in official correspondence.