Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018994219

FEI Number

3018994219

Entity Name

TSINGTAO RZ-LABS CO LTD

City/State/Country

Qingdao Shandong, CN

Establishment Address

Qingdao Industrial Technology Research Institute, Songyuan Road Qingdao National High Tech Development Zone, Qingdao Shandong 266111, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tsingtao RZ-Labs Co Ltd (Owner Number: 10081370)

Owner / Operator Contact Address

Qingdao Industrial Technology Research Institute, Songyuan Road Qingdao National High Tech Development Zone, Qingdao, CN-SD 266111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HOT/COLD THERAPY GEL PAD

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	2021-04-07

Official Correspondent

JUNHAO WANG

US Agent Details

Katla Axelsdottir Business: Ossur Email: kaxelsdottir@ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

Tsingtao RZ-Labs 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 3018994219. Last updated year: 2026. Please use registration number 3018994219 when referencing this establishment in official correspondence.