Terumo Medical Products (Hangzhou) Co., Ltd.

Manufacturer and brand owner in Hangzhou, Zhejiang, China. 7 device types, 7 products catalogued, 5 clearances.

Registry build 21.09.26

Terumo Medical Products (Hangzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clamp, Vascular, Midline Catheter and 5 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.

7device types registered with the FDA
7products catalogued under its own name
5510(k) clearances

Registration

FDA registration record for Terumo Medical Products (Hangzhou) Co., Ltd.
Registered name TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
Status Registered
Registration expires 2026
Registration number 3004102031
FEI number 3004102031
DUNS 544830912
Establishment type Contract manufacturer, Contract steriliser, Manufacturer

Chinese Registration

Chinese company register details for Terumo Medical Products (Hangzhou) Co., Ltd.
Chinese legal name 泰尔茂医疗产品(杭州)有限公司
Source export sales certificate, Zhejiang medical products administration

Location

Address of Terumo Medical Products (Hangzhou) Co., Ltd.
City Hangzhou
Province Zhejiang
Address M4-9-5,HANGZHOU ECONOMIC &
Postal code 310018
Country China

What It Makes

Own-Brand Listings

Devices catalogued by Terumo Medical Products (Hangzhou) Co., Ltd.
Product Code Catalogue numbers
Surflo Hybria FOZ 21
Surflo FPA 19
Surshield FPA 14
Surflo Midela FOZ 10
TR Band DXC 2
Radifocus MOF 1
Surflo Midela KMK 1

Clearances

5 clearances name Terumo Medical Products (Hangzhou) Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Terumo Medical Products (Hangzhou) Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K252402 2025-12-18 PND Traditional This company
K252398 2025-12-17 FOZ Traditional This company
K221411 2023-06-23 FPA Traditional This company
K220934 2022-06-29 MOF Traditional This company
K031279 2003-05-30 FPA Traditional This company
K031266 2003-05-30 FPA Traditional Terumo Corp.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Terumo Medical Products (Hangzhou) Co., Ltd.
Founded 1995
Factory area 114000 m²
Main products Disposable medical devices, Blood collection systems, Apheresis systems, Cardiovascular devices, Medical instruments
Certifications ISO13485, CE, MDSAP, FDA
Export markets Over 150 countries and regions

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

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2,581device types they are registered for
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