Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681839

FEI Number

3002808337

Entity Name

Terumo Corporation Fujinomiya Factory

City/State/Country

FUJINOMIYA-SHI Shizuoka, JP

Establishment Address

818, MISONODAIRA, FUJINOMIYA-SHI Shizuoka 418-0004, 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

BK950058

PMA Number

N/A

All Registered Proprietary Names

Terumo Sampling Site Coupler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2007-11-29

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
3013874291	ME Center (Nagaizumi) of Terumo Corp	Sunto-gun, Shizuoka, JP
8010026	TERUMO CORP.	SHIBUYA-KU, TOKYO, JP
9681834	ASHITAKA FACTORY OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681839. Last updated year: 2026. Please use registration number 9681839 when referencing this establishment in official correspondence.