What is FDA product code EOB?

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 › SurgicalNasopharyngoscope (Flexible Or Rigid)

MiiS Horus Scope

Name: MiiS Horus scope
Brand: MiiS Horus scope

Nasopharyngoscope (model name: EES 100) is a single-use, flexible, sterile nasopharyngoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the…

Registry build 21.09.26

Nasopharyngoscope (model name: EES 100) is a single-use, flexible, sterile nasopharyngoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected Video Box (EVS 100A). The function of ENT Nasopharyngoscope and Accessories are to provide live imaging of the nasal tissue, including tissue appearance recording, snapshot, vertical flip and horizontal flip. The device does not provide any instruction for diagnosis nor treatment.

7manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (2), Hunan (2).

Chinese manufacturers registered for FDA product code EOB
Manufacturer	City	Province	Registered as	Device types
Shenzhen Hugemed Medical Technical Development Co., Ltd.	Shenzhen	Guangdong	Manufacturer	22
Suzhou Virgil Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Scivita Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	19
Hunan Vathin Medical Instrument Co., Ltd.	Xiangtan	Hunan	Manufacturer	6
Jiana Sterilization Technology (Changsha) Co., Ltd.	Changsha	Hunan	Contract manufacturer	4
Zhuhai Wesee Meditech Co., Ltd.	Zhuhai	Guangdong	Manufacturer	2
Liaoning Jrsd Commercial AND Trading Co., Ltd.	Shenyang	Liaoning	Manufacturer	2

Record

Regulatory record for MiiS Horus scope
Listed by	Medimaging Integrated Solution Inc., Taiwan
FDA product code	EOB
Device type	Nasopharyngoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4760
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2026-04-29

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Packaging	White box of 5, carton of 4

Catalogue Numbers

Catalogue numbers for MiiS Horus scope
Catalogue number	Size	Status
5001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nasopharyngoscope (Flexible Or Rigid)	Karl Storz GmbH & Co. KG	174
Hopkins	Karl Storz GmbH & Co. KG	99
Jedmed	Jedmed Instrument Company	70
Endo-Scrub®	Medtronic Xomed, Inc.	51
AED	National Advanced Endoscopy Devices, Inc.	49
Sinuscope	Sopro-Comeg GmbH	32
Sharpsite	Medtronic Xomed, Inc.	30
Slide-ON®	Medtronic Xomed, Inc.	29
Slide-ON® Endosheath®	Medtronic Xomed, Inc.	28
Sinuscope	Ecleris SRL	27
Nasopharyngoscope (Flexible Or Rigid)	Pentax of America, Inc.	26
Flex	Medrobotics Corporation	24

Showing 12 of 147. All products under Nasopharyngoscope (Flexible Or Rigid)

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.