Imovifa
An imovifa is used to perform visual field testing by recording the patient's reaction to small light spots automatically displayed at various positions.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Chongqing (4), Jiangsu (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Main Meditech Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Chongqing SS Medical Equipments Co., Ltd. | Chongqing | Chongqing | Manufacturer | 3 |
Record
| Listed by | Crewt Medical Systems, Inc, Japan |
|---|---|
| FDA product code | HPT |
| Device type | Perimeter, Automatic, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1605 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 40 °C; Storage environment humidity 30 to 75 % RH; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 75 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| imovifa | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perimeter | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 7 |
| Perimeter, Automatic, Ac-Powered | Chongqing Kanghuaruiming S&T Co., Ltd.. | 7 |
| Automated Perimeter | Optopol Technology SP Z O O | 5 |
| Virtual Field | Virtual Field, Inc | 4 |
| Humphrey Field Analyzer 3 (HFA3) | Carl Zeiss Meditec Inc | 4 |
| Carrot | Virtual Field, Inc | 3 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 2 |
| SYL | Chongqing SS Medical Equipments Co., Ltd. | 2 |
| VisionOne | PeriVision SA | 2 |
| RetinaLogik | Retinalogik Inc. | 2 |
| Maia | Centervue | 2 |
| Medmont Automated Perimeter DAC | Medmont International PTY Ltd | 1 |
Showing 12 of 34. All products under Perimeter, Automatic, Ac-Powered
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.