I.terminal 2 Station
Catalogue number 000000-2433-519, listed by Carl Zeiss Vision Gmbh, Germany, under Stand, Instrument, Ac-Powered, Ophthalmic. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (1), Shaanxi (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 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
Record
| Listed by | Carl Zeiss Vision Gmbh, Germany |
|---|---|
| FDA product code | HMF |
| Device type | Stand, Instrument, Ac-Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1860 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-01 |
| Record revised | 2022-01-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure up to 795 millibar; Storage environment humidity 10 to 85 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000000-2433-519 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Reliance | Haag-Streit USA, Inc. | 19 |
| AtriCure System Cart | Atricure, Inc. | 19 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 13 |
| Refraction Unit | MDT SP. Z O.O. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 10 |
| Marco | Takagi Seiko Co., Ltd. | 7 |
| Mckesson | Mckesson Medical-Surgical Inc. | 6 |
| IS-5500 | Topcon Corp. | 5 |
| IS-5000 | Topcon Corp. | 2 |
| KXL System | Avedro, Inc. | 2 |
| IS-6500 | Topcon Corp. | 2 |
| Legion | Alcon Laboratories, Inc. | 1 |
Showing 12 of 19. All products under Stand, Instrument, Ac-Powered, 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.