What is FDA product code EOQ?

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Ear Nose & Throat › SurgicalBronchoscope (Flexible Or Rigid)

Galaxy System – HK

Catalogue number GALRB-HK-001, listed by Noah Medical Corp., United States, under Bronchoscope (Flexible Or Rigid). 21 manufacturers in China are registered for this product code.

Registry build 21.09.26

21manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

5recalls on this code

Who Else Makes It

Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EOQ
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
Guangdong MacroLux Medical Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	9
Ningbo Wise Optomech Technology Corporation	Ningbo	Zhejiang	Contract manufacturer	4
Hangzhou Broncus Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	1
Tianjin Puli Ark Medical Technology Co., Ltd.	Dongli District	Tianjin	Contract manufacturer	1
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Zhejiang Huanyi Sterilization Technology Co., Ltd.	Huzhou	Zhejiang	Contract manufacturer	25
Shenzhen Hugemed Medical Technical Development Co., Ltd.	Shenzhen	Guangdong	Manufacturer	22
Suzhou Prosteri Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Suzhou Virgil Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Scivita Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	19
Anrei Medical (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	12

Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)

Record

Regulatory record for Galaxy System – HK
Listed by	Noah Medical Corp., United States
FDA product code	EOQ
Device type	Bronchoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4680
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2026-04-21
Record revised	2026-07-30 (version 2)

Specifications

Specifications
MRI safety	MR Safe
Prescription	Prescription only
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Galaxy System – HK
Catalogue number	Size	Status
GALRB-HK-001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bronchoscope (Flexible Or Rigid)	Karl Storz GmbH & Co. KG	248
Pentax	Hoya Corporation	39
Biopsy Forceps	Olympus Medical Systems Corp.	31
Single-Use flexible Video Bronchoscope	Hunan Vathin Medical Instrument Co., Ltd.	27
Pilling	Teleflex Medical LLC	24
Silicone cap	Efer Endoscopy	22
Bronchoscope (Flexible Or Rigid)	Intuitive Surgical, Inc.	20
Endoso	Hunan Endoso Life Technology Co., Ltd.	20
Exalt ™	Boston Scientific Corporation	17
Grasping Forceps	Olympus Medical Systems Corp.	16
LungVision Tool	Body Vision Medical Ltd	16
Fujifilm	Fujifilm Corporation	15

Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K223144	2023-03-01

Recalls

5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2025-09-12	Class II	Under Investigation by firm	Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.	47
2024-10-28	Class II	Component change control	Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when	18
2024-10-25	Class II	Device Design	Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissu	26
2024-10-25	Class II	Device Design	Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal	26
2024-03-09	Class II	Process control	Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.	17 wired controllers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.