AincA®
AincA VideoStylet System, Model "B" stylet (length = 33.5cm / 13.2"), LCD Video Monitor, USB Charger/Cable
12manufacturers in China registered for this device type
11catalogue 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.
| 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
| Listed by | Anesthesia Associates, Inc., United States |
|---|---|
| FDA product code | CAL |
| Device type | Laryngoscope, Non-Rigid |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5530 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-31 |
| Record revised | 2025-03-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-675-LCD | In distribution | |
| 00-675-B | In distribution | |
| 00-675-B-DEMO | In distribution | |
| 00-675-C | In distribution | |
| 00-675-A | In distribution | |
| 00-675-C-1 | In distribution | |
| 00-675-V | In distribution | |
| 00-675-V-1 | In distribution | |
| 00-675-B-1 | In distribution | |
| 00-675-CASE | In distribution | |
| 00-675-A-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Laryngoscope, Non-Rigid | Karl Storz GmbH & Co. KG | 23 |
| 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 |
| C-MAC | Karl Storz GmbH & Co. KG | 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.