Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013521527

FEI Number

3013521527

Entity Name

MEDICATEC INC.

City/State/Country

Yashio-shi Saitama, JP

Establishment Address

1-11-28, Chuo, Yashio-shi Saitama 340-0816, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Medicatec Inc. (Owner Number: 10054577)

Owner / Operator Contact Address

1-11-28, Chuo, Yashio-shi, JP-11 340-0816, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112910

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2017-04-12

Official Correspondent

Miu Enoki

US Agent Details

Krishna Sudhakaran Business: Canon Medical Diagnostics USA, Inc. Email: ksudhakaran@mdu.medical.canon Phone: (650) 8106821

Related Public Records

Same Entity

Medicatec Inc.

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
K874883	Incstar Corp.	WALNUT ALLERGEN DISC	1988-05-11
K935876	Bio-Rad Laboratories, Inc.	ACCESS SPECIFIC IGE ASSAY	1994-03-11
K093987	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6	2011-03-28
K132801	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY	2014-05-28

Similar Registrations

Registration Number	Establishment Name	Location
3039353646	PHADIA AB	Uppsala, SE
3002806944	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	LLANBERIS Wales, GB
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
9610566	PHADIA AB	UPPSALA, SE
3004973408	PHADIA US INC.	Portage, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013521527. Last updated year: 2026. Please use registration number 3013521527 when referencing this establishment in official correspondence.