Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004102031

FEI Number

3004102031

Entity Name

TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

M4-9-5,HANGZHOU ECONOMIC &, TECHNOLOGICAL DEVELOPMENT ZONE, HANGZHOU Zhejiang 310018, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Terumo Medical Products (Hangzhou) Co., LTD. (Owner Number: 10033965)

Owner / Operator Contact Address

M4-9-5, Hangzhou Economic &, Technological Development Zone, Hangzhou, CN-ZJ 310018, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252398

PMA Number

N/A

All Registered Proprietary Names

Surshield® Safety Winged Blood Collection Set Surshield® Safety Winged Infusion Set SURFLO® Winged Infusion Set with Needle Protection SURFLO Midela Midline Catheter RADIFOCUS Torque Device SURFLO MIDELA Securement Device Surflo Winged Infusion Set SURFLO Hybria Closed System Safety IV Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-10-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-10-22
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-01-26
PND	Midline Catheter	General Hospital	Class 2	880.5200	2026-01-26
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2022-06-30
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2022-06-30
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2026-01-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-06-26
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-03-06

Official Correspondent

No official correspondent registered.

US Agent Details

Dina Justice Business: Terumo Medical Corp. Email: dina.justice@terumomedical.com Phone: (410) 3927226

Related Public Records

Same Entity

Terumo Medical Products (Hangzhou) 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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

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3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004102031. Last updated year: 2026. Please use registration number 3004102031 when referencing this establishment in official correspondence.