Inami
Universal Trial Frame
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
Record
| Listed by | Inami & Co., Ltd., Japan |
|---|---|
| FDA product code | HPA |
| Device type | Frame, Trial, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1415 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-27 |
| Record revised | 2024-04-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K-0391 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Marco | Takagi Seiko Co., Ltd. | 2 |
| Retinoscopy rack with slider | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Universal Trial Frame UB 3+ | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Half-eye Trial Frame for children, adjustable nose piece | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Universal Trial Frame UB 5 | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Inami Ophthalmic Instruments | Inami & Co., Ltd. | 1 |
| Alcon | Alcon Laboratories, Inc. | 1 |
| Universal Trial Frame UB 4 | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Half-eye Trial Frame, adjustable nose piece | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Half-eye Trial Frame, rigid nose bridge | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Universal Trial Frame UB 4, ‘essilor’ ESS304 | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Half-eye Trial Frame for children, rigid nose bridge | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
Showing 12 of 15. All products under Frame, Trial, Ophthalmic
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.