Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004167884

FEI Number

3004167884

Entity Name

PHC Corporation

City/State/Country

MIMA Tokushima, JP

Establishment Address

110 OAZA-INOSHIRI-AZA-NISHIUENO, WAKIMACHI, MIMA Tokushima 779-3603, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PHC Corporation (Owner Number: 9052268)

Owner / Operator Contact Address

2131-1 MINAMIGATA, TOON, JP-38 791-0395, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Contour Next, Contour Next Link, Contour Next One Contour Next Link 2.4 Contour Next Link 2.4 CONTOUR NEXT Test Strip Contour Next Link 2.4 CONTOUR NEXT ONE Blood Glucose Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2018-05-02
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-04-07
OZO	Automated Insulin Dosing , Threshold Suspend	Unknown	Class 3	N/A	2020-04-07
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-08-09
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-08-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-08-09
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2014-11-14
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2017-12-19
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2020-04-07
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2015-03-24
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-11-23
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-11-23
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-08-07
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-08-07

Official Correspondent

TOSHIHARU YOSHIOKA

US Agent Details

STEVEN HUBBARD Business: PHC CORPORATION OF NORTH AMERICA Email: steven.hubbard@us.phchd.com Phone: (551) 4829284

Related Public Records

Same Entity

PHC Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9616263	PHC Corporation	Ora-gun Gunma, JP
3029973107	PHC Corporation	Tako-machi Katori-gun Chiba, JP
1000134386	PHC Corporation	TOON Ehime, JP
3014353045	PHC Corporation	Chiyoda-ku Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K973662	Boehringer Mannheim Corp.	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	1997-12-15
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0001-2025	Medtronic MiniMed, Inc.	3	MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851

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3003366417	LRE MEDICAL GMBH	NOERDLINGEN Bavaria, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004167884. Last updated year: 2026. Please use registration number 3004167884 when referencing this establishment in official correspondence.