Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010410654

FEI Number

3010410654

Entity Name

Tiantai Shengtengyun Medical Supplies Co., Ltd.

City/State/Country

TIANTAI COUNTY Zhejiang, CN

Establishment Address

No.4,Zone B,No.20Shifeng East Road,Fuxi Street high-tech industrial park, TIANTAI COUNTY Zhejiang 317200, 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,Manufacture Medical Device

Owner / Operator

Tiantai Shengtengyun Medical Supplies Co., Ltd (Owner Number: 10043944)

Owner / Operator Contact Address

No.4,Zone B,No.20Shifeng East Road,Fuxi Street high-tech industrial park, Tiantai County, CN-ZJ 317200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tourniquet Cuff; Cuff; Medical Tourniquet Cuff Disposable Tourniquet Cuff; Single Use Tourniquet Cuff; Pneumatic Tourniquet; Reusable Tourniquet Cuff; Pressure infusion bag Disposable Tourniquet Cuff; Single Use Tourniquet Cuff; Pneumatic Tourniquet; Reusable Tourniquet Cuff; Tourniquet Cuff; Cuff; Medical Tourniquet Cuff

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2023-03-01
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2024-06-26
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2013-04-10

Official Correspondent

Choujie Pei

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Tiantai Shengtengyun Medical Supplies 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 3010410654. Last updated year: 2026. Please use registration number 3010410654 when referencing this establishment in official correspondence.