Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010227982

FEI Number

3010227982

Entity Name

Tianjin Zhengtian Medical Instrument Co., Ltd.

City/State/Country

Tianjin, CN

Establishment Address

No. 318, Jingyi Road, Airport Economic Zone, Tianjin 300308, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tianjin Zhengtian Medical Instrument Co., Ltd. (Owner Number: 10048833)

Owner / Operator Contact Address

No. 318, Jingyi Road, Airport Economic Zone, CN-TJ 300308, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable face mask Inion Thermo Waterbath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-18
IRQ	Unit, Heating, Powered	Physical Medicine	Class 1	890.5950	2016-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

Rebecca Proulx Business: Inion, Inc. Email: rebecca.proulx@inion.com Phone: (954) 6599224

Related Public Records

Same Entity

Tianjin Zhengtian Medical Instrument 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 3010227982. Last updated year: 2026. Please use registration number 3010227982 when referencing this establishment in official correspondence.