Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681835

FEI Number

3003752255

Entity Name

KOFU FACTORY OF TERUMO CORP.

City/State/Country

NAKAKOMA-GUN Yamanashi, JP

Establishment Address

1727-1 TSUIJIARAI, SHOWA-CHO, NAKAKOMA-GUN Yamanashi 409-3853, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TERUMO CORP. (Owner Number: 8010026)

Owner / Operator Contact Address

44-1, 2-CHOME, HATAGAYA, --, SHIBUYA-KU, TOKYO, JP-NOTA 151-0072, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190427

PMA Number

N/A

All Registered Proprietary Names

Terumo Sterile Tubing Welder (TSCD) TSCD Wafers Surflo Winged Infusion Set TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER Immucise Intradermal Injection System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	1996-08-21
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2010-03-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-05-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-05-28

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 CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3013611763	Terumo Yamaguchi Corporation	Yamaguchi-shi, JP
9681839	Terumo Corporation Fujinomiya Factory	FUJINOMIYA-SHI Shizuoka, JP
3013874291	ME Center (Nagaizumi) of Terumo Corp	Sunto-gun, Shizuoka, JP
8010026	TERUMO CORP.	SHIBUYA-KU, TOKYO, JP

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

Registration Number	Establishment Name	Location
9710609	RACER TECHNOLOGY PTE LTD	SINGAPORE South East, SG
3004548776	FENWAL, INC.	LAKE ZURICH, IL, US
3004634229	FRESENIUS HEMOCARE GMBH	Friedberg Hesse, DE
2248588	GENESISBPS LLC	Mahwah, NJ, US
1722028	Terumo BCT, Inc..	Lakewood, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681835. Last updated year: 2026. Please use registration number 9681835 when referencing this establishment in official correspondence.