Manufacturer

Insighters

ChinaLegal entities : SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.

First countries of placing on the market declared in EUDAMED : Denmark, Estonia, Germany, Hungary, Italy, Slovakia, Spain

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

6 categories, 19 models including 19 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Video laryngoscopes	Z12021004	Video Laryngoscope Accessories insight iS6 Video laryngoscope insight iS2 Video laryngoscope insight iS393/42 Video laryngoscope iS3-C393/42 Video laryngoscope iS3-C493/42 7 others Video laryngoscope iS3-C593/42 Video laryngoscope iS3-C693/42 Video laryngoscope iS3-F293/42 Video laryngoscope iS3-F393/42 Video laryngoscope iS3-FN293/42 Video laryngoscope iS3-R93/42 Video Laryngoscope Pediatric iS-NEO	I MDR, 93/42	EUDAMED record Report an error
ENT endoscopy instruments - other	Z12021099	Laryngoscope blade MAC1、MAC2、MAC3、MAC43 refs Reusable Laryngoscope Blade SS, S, M, L3 refs	I MDR	EUDAMED record Report an error
Video nasopharyngo/laryngoscopes	Z12021006	Electronic Nasopharyngeal Endoscope iS-HNF32, iS-HNF45, iS-HNC42, iS-HNC49, iS-HNC56, iS-HNF32L, iS-HNF45L, iS-HNC42L, iS-HNC49L, iS-HNC56L Electronic Nasopharyngeal Endoscope iS-QNF20, iS-QNF30, iS-QNF36, iS-QNC30, iS-QNC37, iS-QNC40, iS-QNC49, iS-QNF20L, iS-QNF30L, iS-QNF36L, iS-QNC30L, iS-QNC37L, iS-QNC40L, iS-QNC49L	I MDR	EUDAMED record Report an error
Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images	Z12020401	Insight Workstation iS-PF1, iS-PF22 refs	I MDR	EUDAMED record Report an error
Video processors	Z12020406	Video Processor iS-HDV1, iS-HDV2	I MDR	EUDAMED record Report an error
Walking trolleys	Y120612	Trolley iS-TC1、iS-TC22 refs	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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