Kinevo® 900
Catalogue number 6640, listed by Carl Zeiss Meditec Inc, United States, under Microscope, Surgical, General & Plastic Surgery. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Chengdu Corder Optics & Electronics Co., Ltd. | Chengdu | Sichuan | Manufacturer | 1 |
| Hefei MAX ACT Medical Equipment Co., Ltd. | Hefei | Anhui | Manufacturer | 1 |
| Shanghai Eder Medical Technology Inc. | Shanghai | Shanghai | Manufacturer | 1 |
| Suzhou Semorr Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Carl Zeiss Meditec Inc, United States |
|---|---|
| FDA product code | FSO |
| Device type | Microscope, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-04-24 |
| Record revised | 2019-08-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6640 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 130 |
| MaxView System – Lateral Set | Viseon, Inc. | 7 |
| S100 / Opmi pico | Carl Zeiss Meditec Inc | 6 |
| S7 / Opmi PROergo | Carl Zeiss Meditec Inc | 6 |
| Aesculap | Aesculap AG | 4 |
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 4 |
| MaxView™ System – Lateral Set with Illumination | Viseon, Inc. | 3 |
| S7 / Opmi Sensera | Carl Zeiss Meditec Inc | 3 |
| Medical Microscope | Denjoy Dental Co., Ltd. | 3 |
| RoboticScope | Bhs Intl., Inc. | 2 |
| Rols Reinverter – Leica+ | Volk Optical Inc. | 2 |
| Rols Reinverter – Zeiss + | Volk Optical Inc. | 2 |
Showing 12 of 130. All products under Microscope, Surgical, General & Plastic Surgery
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.