Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004699328

FEI Number

3004699328

Entity Name

KYOWA, LTD.

City/State/Country

IZUMISANO-CITY Osaka, JP

Establishment Address

4-81, TSURUHARA 4-CHOME, IZUMISANO-CITY Osaka 598-0071, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KYOWA, LTD. (Owner Number: 9067670)

Owner / Operator Contact Address

20-28, TACHIBANA 3-CHOME, NISHINARI-KU, OSAKA-CITY, OSAKA, JP-NOTA 557-0051, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

POLIGRIP COMFORT STRIPS POLYGRIP COMFORT STRIPS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOL	Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer	Dental	Class 1	872.3410	2004-10-27

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Hall Business: Scapa Tapes North America LLC Email: randy.hall@mativ.com Phone: (865) 2787235

Related Public Records

Same Entity

KYOWA, LTD.

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

View Entity Profile →

Similar Registrations

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3009171220	DENTIMED SAO JOAO	Sunrise, FL, US
3015200795	Scapa Tapes North America, LLC	Knoxville, TN, US
1520597	CRESCENT MFG. CO.	FREMONT, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004699328. Last updated year: 2026. Please use registration number 3004699328 when referencing this establishment in official correspondence.