Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013284090

FEI Number

3013284090

Entity Name

SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

H&T Ind. Park, Genyu Rd. East, Mold Base, Gongming Office,Guangming New Dist., Shenzhen Guangdong 518106, CN

Establishment Type(s)

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

Owner / Operator

Shenzhen H&T Intelligent Control Co., Ltd. (Owner Number: 10057032)

Owner / Operator Contact Address

H&T Ind. Park, Genyu Rd. East, Mold Base, Gongming Office,Guangming New Dist., Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clearblue

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2018-02-12
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2018-03-22

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

Shenzhen H&T Intelligent Control 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013284090. Last updated year: 2026. Please use registration number 3013284090 when referencing this establishment in official correspondence.