Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042158672

FEI Number

3042158672

Entity Name

ENDOSEMIO CO., LTD.

City/State/Country

Zhubei City Hsinchu, TW

Establishment Address

2F.-3, No. 6-1, Sec. 2, Shengyi Rd.,, Zhubei City Hsinchu 302058, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

ENDOSEMIO CO., LTD. (Owner Number: 10094078)

Owner / Operator Contact Address

2F.-3, No. 6-1, Sec. 2, Shengyi Rd.,, Zhubei City, TW-HSQ 302058, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LRG-01 Video Laryngoscope ORL-001 digital otoscope set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2025-11-24
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2025-11-24

Official Correspondent

Liang Tong Kuo

US Agent Details

Chia-Li Chen Email: cchen065@gmail.com Phone: (619) 7636595

Related Public Records

Same Entity

ENDOSEMIO CO., LTD.

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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

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 3042158672. Last updated year: 2026. Please use registration number 3042158672 when referencing this establishment in official correspondence.