Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681246

FEI Number

3002807522

Entity Name

MACHIDA ENDOSCOPE CO., LTD.

City/State/Country

Abiko Chiba, JP

Establishment Address

15-12 Abiko 1 Chome, Abiko Chiba 270-1166, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MACHIDA ENDOSCOPE CO., LTD. (Owner Number: 9020972)

Owner / Operator Contact Address

15-12 Abiko 1 Chome, Abiko, JP-12 270-1166, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MACHIDA MACHIDA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2001-08-12
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-03-13

Official Correspondent

Shunsuke Komatsu

US Agent Details

Dustin Biggerstaff Business: JEDMED Email: DustinB@jedmed.com Phone: (314) 8453770

Related Public Records

Same Entity

MACHIDA ENDOSCOPE CO., LTD.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681246. Last updated year: 2026. Please use registration number 9681246 when referencing this establishment in official correspondence.