Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000279801

FEI Number

3000279801

Entity Name

OPCOM INC.

City/State/Country

New Taipei City, TW

Establishment Address

12F, No.8, Jiankang Rd., Zhonghe Dist.,, New Taipei City 23586, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OPCOM Inc. (Owner Number: 10084244)

Owner / Operator Contact Address

12F, No.8, Jiankang Rd., Zhonghe Dist.,, 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

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2022-09-19
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2024-05-19
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-11-03
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-28
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2023-08-08
ELK	Teeth, Artificial, Backing And Facing	Dental	Class 1	872.3910	2024-05-19
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2022-09-19
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-28
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-12-19
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-12-07
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-28
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-01-28

Official Correspondent

Coco Yao

US Agent Details

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

Related Public Records

Same Entity

OPCOM 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

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
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000279801. Last updated year: 2026. Please use registration number 3000279801 when referencing this establishment in official correspondence.