FNS-3200
Laringoscope Non Rigid 3,2 mm.
12manufacturers in China registered for this device type
1catalogue number
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 | Ecleris SRL, Argentina |
|---|---|
| FDA product code | CAL |
| Device type | Laryngoscope, Non-Rigid |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5530 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 15 to 36 °C; Handling environment humidity 40 to 65 % RH; Handling environment atmospheric pressure 0 to 100 KiloPascal; Storage environment temperature 15 to 30 °C; Storage environment humidity 0 to 0 % RH; Storage environment atmospheric pressure 0 to 100 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RX1 | In distribution |
Same 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 |
| C-MAC | Karl Storz GmbH & Co. KG | 2 |
| FNS-2800 | 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.