Head-Up-Display, HUD-1
HUD-1, Final Assembly, IRIDEX
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
| Langfang FAR East Prosperous Optical Instrument Co., Ltd. | Langfang | Hebei | Contract manufacturer | 5 |
| Shanghai Huvitz Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
Record
| Listed by | Iridex Corporation, United States |
|---|---|
| FDA product code | HOS |
| Device type | Projector, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1680 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-12-05 |
| Record revised | 2024-05-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 90 % RH; Storage environment temperature -10 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Head-Up-Display, HUD-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2 |
| Takagi | Takagi Seiko Co., Ltd. | 1 |
| Head-Up-Display, HUD-1 | Topcon Medical Laser Systems, Inc. | 1 |
| Chart Projector CCP-3100 | Huvitz Co., Ltd. | 1 |
| Chart Projector HCP-7000 | Huvitz Co., Ltd. | 1 |
| CP 550 | Essilor International | 1 |
| Auto chart projector | Ningbo Ming Sing Optical R&D Co., Ltd. | 1 |
| VisiChart | Topcon Corp. | 1 |
| Auto Chart Projector ACP-8 | Topcon Corp. | 1 |
| Medizs Auto Chart Projector CP-11 | Medizs Inc. | 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.