Laryngoscope, Non-Rigid

Which Manufacturers in China Make This?

12 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Zhejiang and Hunan, and 2 other provinces. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Boen Healthcare Co., Ltd. Jiangsu
Changsha Magill Medical Technology Co., Ltd. Hunan
Hangzhou Shanyou Medical Equipment Co., Ltd. Zhejiang
Sensorendo Medical Technology (Zhuhai) Co., Ltd. Guangdong, contract manufacturer
Shenzhen Coreray Technology Co., Ltd. Guangdong
Shenzhen Hugemed Medical Technical Development Co., Ltd. Guangdong
Shenzhen Insighters Medical Technology Co., Ltd. Guangdong, contract manufacturer
Shenzhen Junyuan Medical Equipment Co., Ltd. Guangdong
Shenzhen Sanping Image Technology Co., Ltd. Guangdong
Xi'an Haiye Medical Equipment Co,.ltd. Shaanxi
Zhongshan Wesee Meditech Co., Ltd. Guangdong, contract manufacturer
Zhejiang UE Medical Corp. Zhejiang

How Is CAL Classified?

Laryngoscope, Non-Rigid is FDA product code CAL, Class 1, 21 CFR 868.5530.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 11 recalls under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Device Design (9).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Laryngoscope, Non-Rigid

Ri-Integral Flex Flexible Blade With Integrated F.

Catalogue number 12250, listed by Rudolf Riester Gmbh, Germany, under Laryngoscope, Non-Rigid. 12 manufacturers in China are registered for this product code.

Laryngoscope, Non-Rigid

C-MAC

Flex. Intubation Video Endoscope 4 x 65

Laryngoscope, Non-Rigid

Optomic

Catalogue number OP-30 Naso-pharyngoscope, listed by Optomic España SA, under Laryngoscope, Non-Rigid. 12 manufacturers in China are registered for this product code.

Laryngoscope, Non-Rigid

Toad™

S-DVL Single use flexible laryngoscope

Laryngoscope, Non-Rigid

Sensorendo

Single Use Flexible Video Laryngoscope Model S-DVL

Laryngoscope, Non-Rigid

FNS-3200

Laringoscope Non Rigid 3,2 mm.

Laryngoscope, Non-Rigid

Insighter

2 catalogue numbers from iS3-F, listed by Shenzhen Insighters Medical Technology Co., Ltd., China, under Laryngoscope, Non-Rigid. 12 manufacturers in China are registered for this product code.

Laryngoscope, Non-Rigid

DCI

DCI® BONFILS Intubation Endoscope 5,0x40

Laryngoscope, Non-Rigid

Videoscope is a assistive device designed to operate in comination with Magill Medical's Disposable Video Laryngeal Mask to allow visualization during the processes of laryngeal mask…

Laryngoscope, Non-Rigid

Flex. Intubation. Video Endoscope 3x51.5

Laryngoscope, Non-Rigid

Which Manufacturers in China Make This?

How Is CAL Classified?

What Does It Take to Sell It in the United States?

What Has Gone Wrong With It?

Ri-Integral Flex Flexible Blade With Integrated F.

C-MAC

Optomic

Toad™

Sensorendo

FNS-3200

Insighter

DCI

Laryngoscope, Non-Rigid

AincA®

Fiber Intubation Scope

FNS-2800

Laryngoscope, Non-Rigid

Where China Actually Supplies