Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021736577

FEI Number

3021736577

Entity Name

Nihon Vinyl Cord Corporation - Kodama Second Factory

City/State/Country

Honjo-shi Saitama, JP

Establishment Address

1404-1 Kodama, Kodama-machi, Honjo-shi Saitama 161-8560, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NIHON KOHDEN CORP. (Owner Number: 8030227)

Owner / Operator Contact Address

1-31-4 NISHIOCHIAI, SHINJUKU-KU, TOKYO, JP-13 161-8560, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TL-631T3 A/NTX-DISP TL-272T3 ZM-530PA ZM-521PA TL-062S ZM-541PA TL-271T TL-274T YN-990P TL-273T3 BR-913PA ZS-940PA YP-504P ZM-520PA YP-944P A/NTX2-POUCH BR-916PA ZM-531PA TL-201T BR-906PA TL-271T3 TL-274T3 BR-903PA TL-052S ZM-540PA YP-503P YP-943P TL-220T BLUPRO Attachment Tape YS-111P7 (P263A) BLUPRO Attachment Tape, YS-111P7

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2007-11-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-06-05

Official Correspondent

No official correspondent registered.

US Agent Details

Charlemagne Chua Business: Nihon Kohden America, LLC Email: charlemagne_chua@nihonkohden.com Phone: (949) 3303964

Related Public Records

Same Entity

NIHON KOHDEN 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
3030154814	Nihon Kohden America Fulfillment Center	Foothill Ranch, CA, US
2032233	Nihon Kohden Digital Health Solutions, LLC.	IRVINE, CA, US
3030516450	Nihon Vinyl Cord Corporation - Shimo-ongata Factory	Hachioji-shi Tokyo, JP
3007481893	Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center	Fukaya-Shi Saitama, JP
3007962724	Nihon Kohden Tomioka Corporation	Gunma Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832250	Litton Medical Electronics	SERVOMED BASIC BEDSIDE UNIT SMA 102-	1984-06-01
K801515	Abbott Medical Electronics Co.	ABBY II PATIENT MONITOR OR VITAL SIGNS M	1980-07-08
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009499478	EDAN Diagnostics, Inc.	San Diego, CA, US
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
3017760831	Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.	Kulim Kedah, MY
3007305624	GUANGDONG BIOLIGHT MEDITECH CO., LTD	Zhuhai Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021736577. Last updated year: 2026. Please use registration number 3021736577 when referencing this establishment in official correspondence.