Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013874291

FEI Number

3013874291

Entity Name

ME Center (Nagaizumi) of Terumo Corp

City/State/Country

Sunto-gun, Shizuoka, JP

Establishment Address

1002-1 Shimonagakubo, Nagaizumi-cho,, Sunto-gun, Shizuoka 411-0934, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K852087

PMA Number

N/A

All Registered Proprietary Names

CAPIOX Luer Thermistor Wire Red Cable (ME Center) CAPIOX Luer Thermistor CAPIOX Luer Thermistor Wire Blue Cable (ME Center)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	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
9681839	Terumo Corporation Fujinomiya Factory	FUJINOMIYA-SHI Shizuoka, JP
8010026	TERUMO CORP.	SHIBUYA-KU, TOKYO, JP
9681834	ASHITAKA FACTORY OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013874291. Last updated year: 2026. Please use registration number 3013874291 when referencing this establishment in official correspondence.