Light, Surgical, Accessories
VPS COM Upgrade
21manufacturers in China registered for this device type
72catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (6), Guangdong (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Rongxing Plastic Jurong Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 8 |
| Shanghai Everpure Plastics Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
Showing 12 of 21. All 21 manufacturers in China registered for Light, Surgical, Accessories
Record
| Listed by | Maquet Gmbh, Germany |
|---|---|
| FDA product code | FTA |
| Device type | Light, Surgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K130513 |
| Record published | 2019-01-21 |
| Record revised | 2025-01-06 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 20 to 75 % RH; Handling environment temperature -10 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 75 % RH; Storage environment temperature -10 to 60 °C |
| Distribution end date | 2023-02-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARD567355972 | In distribution | |
| ARD567355973 | In distribution | |
| ARD569203932 | In distribution | |
| ARD569203913 | In distribution | |
| ARD567355934 | In distribution | |
| ARD567355953 | In distribution | |
| ARD567355955 | In distribution | |
| ARD567355978 | In distribution | |
| ARD569203934 | In distribution | |
| ARD569203911 | In distribution | |
| ARD569203907 | In distribution | |
| ARD569203902 | In distribution | |
| ARD569203961 | In distribution | |
| ARD569203904 | In distribution | |
| ARD567355976 | In distribution | |
| ARD569203951 | In distribution | |
| ARD569203930 | In distribution | |
| ARD567355977 | In distribution | |
| ARD567355946 | In distribution | |
| ARD567355959 | In distribution | |
| ARD569203916 | In distribution | |
| ARD569203912 | In distribution | |
| ARD569203908 | In distribution | |
| ARD569203900 | In distribution | |
| ARD569203905 | In distribution | |
| ARD569203910 | In distribution | |
| ARD567355948 | In distribution | |
| ARD569203935 | In distribution | |
| ARD569203914 | In distribution | |
| ARD567355930 | In distribution | |
| ARD567355935 | In distribution | |
| ARD567355979 | In distribution | |
| ARD569203919 | In distribution | |
| ARD567355956 | In distribution | |
| ARD569203923 | In distribution | |
| ARD569203922 | In distribution | |
| ARD569203950 | In distribution | |
| ARD567355950 | In distribution | |
| ARD567355975 | In distribution | |
| ARD567355974 | In distribution | |
| ARD569203931 | In distribution | |
| ARD569203917 | In distribution | |
| ARD567355952 | In distribution | |
| ARD569203920 | In distribution | |
| ARD569203901 | In distribution | |
| ARD567355912 | In distribution | |
| ARD569203906 | In distribution | |
| ARD567355951 | In distribution | |
| ARD569203952 | In distribution | |
| ARD569203953 | In distribution | |
| ARD567355911 | In distribution | |
| ARD567355945 | In distribution | |
| ARD567355947 | In distribution | |
| ARD569203921 | In distribution | |
| ARD569203903 | In distribution | |
| ARD569203933 | In distribution | |
| ARD569203918 | In distribution | |
| ARD569203915 | In distribution | |
| ARD569203909 | In distribution | |
| ARD569203955 | In distribution | |
| ARD568407929 | Withdrawn | |
| ARD568407901 | Withdrawn | |
| ARD568407903 | Withdrawn | |
| ARD568407908 | Withdrawn | |
| ARD568407927 | Withdrawn | |
| ARD568407905 | Withdrawn | |
| ARD568407906 | Withdrawn | |
| ARD568407916 | Withdrawn | |
| ARD568407915 | Withdrawn | |
| ARD568407928 | Withdrawn | |
| ARD568407902 | Withdrawn | |
| ARD568407904 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aspen® Flexible Light Handle Adapter | Aspen Surgical Products, Inc. | 290 |
| Litex | Litex Manufacturing, Inc. | 226 |
| DeRoyal | Deroyal Industries, Inc. | 215 |
| Aspen® Rigid Light Handle Adapter | Aspen Surgical Products, Inc. | 212 |
| Medical Action Industries | Medical Action Industries, Inc. | 42 |
| Olympus | Gyrus Acmi, Inc. | 37 |
| Aspen® Flexible Light Handle Cover | Aspen Surgical Products, Inc. | 14 |
| Helion | Videomed SRL | 14 |
| Cardinal Health | Cardinal Health 200, LLC | 13 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 8 |
| Aspen® Rigid Light Handle Cover | Aspen Surgical Products, Inc. | 6 |
| Light, Surgical, Accessories | Steris Corporation | 6 |
Showing 12 of 74. All products under Light, Surgical, Accessories
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.