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SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.

China·CN-MF-000032018

Last updated September 17, 2026

Information

Country: China
Address: Ganli Road No. 3, The 13th Floor of Hengtemei Building, Ganli Road No. 3, 518000 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA, SHEN ZHEN, China
Website: www.insighters.cn/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-755-89313133
PRRC Contact: Qingqing Zhang
EUDAMED SRN: CN-MF-000032018
FDA FEI Number: 3013528571
DUNS Number: —

Catalogue (18)

Device	Model / Reference	Registries	Class	Status
Electronic Nasopharyngeal Endoscope	iS-ENC32	EUDAMED	Class I	Active
Electronic Nasopharyngeal Endoscope	iS-ENC42	EUDAMED	Class I	Active
Laryngoscope blade	MAC2	EUDAMED	Class I	Active
Laryngoscope blade	MAC4	EUDAMED	Class I	Active
Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.	K242793	EUDAMEDFDA 510(k)	Class II	Active
Disposable Double Lumen Endobronchial Tube	K232529	FDA 510(k)	Class II	Active
Disposable Endobronchial Blocker Tube	K232580	FDA 510(k)	Class II	Active
Single-Use Laryngoscope Blade	iSSULB6SS	EUDAMED	Class I	Active
Video laryngoscope	/	EUDAMED	Class IIa	Active
Trolley	15-618	EUDAMED	Class I	Active
Electronic Nasopharyngeal Endoscope	iS-ENF22	EUDAMED	Class I	Active
Single-Use Laryngoscope Blade	iSSULB3MAC3	EUDAMED	Class I	Active
Laryngoscope blade	15-558	EUDAMED	Class I	Active
Stylet	13-833	EUDAMED	Class I	Active
Single-Use Laryngoscope Blade	iSSULB3MAC4	EUDAMED	Class I	Active
Video Laryngoscope Pediatric	iS-NEO	EUDAMED	Class I	Active
Single-Use Laryngoscope Blade	iSSULB3SS	EUDAMED	Class I	Active
Single-Use Laryngoscope Blade	iSSULB3L	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Shenzhen Insighters Medical Technology Co., Ltd. US