Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010452651

FEI Number

3010452651

Entity Name

Xiamen Tianzuo Medical Co., Ltd.

City/State/Country

Xiamen Fujian, CN

Establishment Address

Area A, 6F, No. 588-1, TongFu Road, TongAn District,, Xiamen Fujian 361100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Xiamen Tianzuo Medical Co., Ltd. (Owner Number: 10057980)

Owner / Operator Contact Address

Area A, 6F, No. 588-1, TongFu Rd., 361100 TongAn Dist.,, Xiamen, CN-FJ 361100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Anesthesia mask CPR FACE SHIELD Emergency CPR Mask CPR Pocket Mask CPR Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2018-06-21
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2019-10-23
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2021-06-30

Official Correspondent

Yi Zheng

US Agent Details

Dennis Xu Business: Performance International, Inc. Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

Xiamen Tianzuo Medical 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
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010452651. Last updated year: 2026. Please use registration number 3010452651 when referencing this establishment in official correspondence.