C-MAC

Flex. Intubation Video Endoscope 4 x 65

Registry build 21.09.26
12manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (7), Zhejiang (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code CAL
Manufacturer City Province Registered as Device types
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shenzhen Hugemed Medical Technical Development Co., Ltd. Shenzhen Guangdong Manufacturer 22
Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Zhejiang Manufacturer 17
Shenzhen Coreray Technology Co., Ltd. Shenzhen Guangdong Manufacturer 8
Zhejiang UE Medical Corp. Xianju Zhejiang Manufacturer 6
Shenzhen Sanping Image Technology Co., Ltd. Shenzhen Guangdong Complaint-file establishment 5
Sensorendo Medical Technology (Zhuhai) Co., Ltd. Zhuhai Guangdong Contract manufacturer 5
Changsha Magill Medical Technology Co., Ltd. Changsha Hunan Complaint-file establishment 4
Xi’an Haiye Medical Equipment Co,.ltd. Xi’An Shaanxi Manufacturer 3
Zhongshan Wesee Meditech Co., Ltd. Zhongshan Guangdong Contract manufacturer 3
Shenzhen Junyuan Medical Equipment Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for C-MAC
Listed by Karl Storz GmbH & Co. KG
FDA product code CAL
Device type Laryngoscope, Non-Rigid
Device class Class 1
Regulation 21 CFR 868.5530
Premarket notification Exempt
Record published 2019-02-23
Record revised 2025-03-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide, Hydrogen Peroxide, Peracetic Acid, High-level Disinfectant
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for C-MAC
Catalogue number Size Status
11302BDX In distribution
11301BNX In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Laryngoscope, Non-Rigid Karl Storz GmbH & Co. KG 23
AincA® Anesthesia Associates, Inc. 11
Laryngoscope, Non-Rigid Changsha Magill Medical Technology Co., Ltd. 6
Fiber Intubation Scope Pentax of America, Inc. 5
Sensorendo Sensorendo Medical Technology (Zhuhai) Co., Ltd. 3
DCI Karl Storz GmbH & Co. KG 2
Insighter Shenzhen Insighters Medical Technology Co., Ltd. 2
Toad™ WM&DG 2
FNS-2800 Ecleris SRL 1
FNS-3200 Ecleris SRL 1
Optomic Optomic España SA 1
ri-integral flex flexible blade with integrated F. Rudolf Riester Gmbh 1

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer