Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012843412

FEI Number

3012843412

Entity Name

BRITEMED TECHNOLOGY INC.

City/State/Country

New Taipei City, TW

Establishment Address

3F., No. 306,306-3, 13F., No. 306,306-3, Sec. 1, Datong Rd., Xizhi Dist.,, New Taipei City 221, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BriteMED Technology Inc. (Owner Number: 10062321)

Owner / Operator Contact Address

3F., No. 306,306-3, 13F., No. 306,306-3, Sec. 1, Datong Rd., Xizhi Dist.,, New Taipei City, TW-TPE 221, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ambu aBox 2; Ambu aScope 5 Broncho HD 5/2.2; Ambu aScope 5 Broncho HD 5.6/2.8 Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance Ambu® SureSight® Mobile Mini Kit Ambu® SureSight® Mobile Kit Ambu® aScope Colon Ambu® aBox 2 Ambu® aBox 2 Ambu® aScope 5 Ureteroscope Ambu® aBox 2 Ambu® aBox 2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2 Ambu aBox 2; Ambu aScope Duodeno 2 Ambu® aScope Gastro Large; Ambu® aBox 2 Ambu® ABox2 Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2020-01-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-08-18
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-01-11
OGH	Laryngoscope Kit	Anesthesiology	Class 1	868.5540	2025-12-03
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-11-02
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-11-02
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-10-28
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-06-25
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-06-25
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-08-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-04-19
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-04-19
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-04-09
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-04-09
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-02-11
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-02-11
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-09-20

Official Correspondent

Janet Lu

US Agent Details

Paul Tseng Business: IEI Technology USA Corporation Email: ptseng@usa.ieiworld.com Phone: (909) 5952819

Related Public Records

Same Entity

BriteMED Technology 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
K940152	Hydro-Med Products, Inc.	CAMERA COVER WITH TEAR TIP	1994-10-28
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Similar Registrations

Registration Number	Establishment Name	Location
3033043422	NOVANTA MEDICAL S.R.O.	Prelouc Pardubicky Kraj, CZ
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP
3004443374	SAPI MED S.P.A	ALESSANDRIA, IT
9610617	KARL STORZ SE & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
3011459664	QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.	Qingdao Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012843412. Last updated year: 2026. Please use registration number 3012843412 when referencing this establishment in official correspondence.