Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033010858

FEI Number

3033010858

Entity Name

OPCOM MEDICAL INC.

City/State/Country

New Taipei City, TW

Establishment Address

12F, No.6, JianKang Rd., Zhonghe Dist., New Taipei City 23586, Taiwan(R.O.C.), New Taipei City 23586, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OPCOM Medical Inc. (Owner Number: 10090696)

Owner / Operator Contact Address

12F, No.6, JianKang Rd., Zhonghe Dist., New Taipei City 23586, Taiwan(R.O.C.), New Taipei City, TW-NWT 23586, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

laryngoscope laryngoscope U-Scope laryngoscope Cystoscope and accessories, flexible/rigid Cystoscope and accessories, flexible/rigid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2024-11-26
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2024-11-26
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-03-03
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-03-03
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2024-11-26
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-11-04
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-04-30

Official Correspondent

Ching Lin Huang

US Agent Details

Shelley Mathews Business: FullCircle26, Inc. Email: shelley.mathews@fullcircle26inc.com Phone: (224) 2802034

Related Public Records

Same Entity

OPCOM Medical 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
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

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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3018366470	MCREAT ( GUANGZHOU ) BIO-TECH CO.,LTD	Guangzhou Guangdong, CN
3000279801	OPCOM INC.	New Taipei City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033010858. Last updated year: 2026. Please use registration number 3033010858 when referencing this establishment in official correspondence.