Barco
MDSC-8532 Sstp BL KIT CM
22manufacturers in China registered for this device type
89catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Guangdong (5), Shanghai (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dentall, Inc. | District | Beijing | Contract manufacturer | 13 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shanghai Suoguang Visual Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Showing 12 of 22. All 22 manufacturers in China registered for Camera, Surgical And Accessories
Record
| Listed by | Barco, Inc, United States |
|---|---|
| FDA product code | KQM |
| Device type | Camera, Surgical And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-01 |
| Record revised | 2024-05-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2022-03-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMM215WTD | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-2232 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8255 | In distribution | |
| AMM215WTTP | In distribution | |
| MDSC-8527 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8331 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-2324 | In distribution | |
| MDSC-8527 | In distribution | |
| MDSC-8527 | In distribution | |
| MDSC-2326 | In distribution | |
| MDSC-8527 | In distribution | |
| MDSC-2232 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8258 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8232 | In distribution | |
| AMM240ED | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8255 | In distribution | |
| MDRC-2222 | In distribution | |
| MDSC-2326 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-2324 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8258 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8331 | In distribution | |
| MDSC-2326 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-2324 | In distribution | |
| MDSC-8527 | In distribution | |
| MDRC-2222 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8255 | In distribution | |
| MDFC-8232 | In distribution | |
| MDSC-8527 | In distribution | |
| MDSC-2326 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8232 | In distribution | |
| MDSC-8532 SSTP | In distribution | |
| MDFC-8232 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8532 | In distribution | |
| MDRC-2222 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-2326 | In distribution | |
| MDSC-2232 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8532 | In distribution | |
| MDFC-8232 | In distribution | |
| MDSC-8532 | In distribution | |
| MDFC-8232 | In distribution | |
| MDSC-8527 SSTP | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-2324 | In distribution | |
| MDSC-2324 | In distribution | |
| MDSC-8532 SSTP BL | In distribution | |
| MDSC-2232 | In distribution | |
| MDSC-8255 | In distribution | |
| MDSC-8532 | In distribution | |
| MDSC-8358 | In distribution | |
| MDSC-8358 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Radiance | NDS Surgical Imaging, LLC. | 129 |
| Accu-Beam | Transamerican Technologies International | 114 |
| Conmed | ConMed Corporation | 59 |
| EndoVue | NDS Surgical Imaging, LLC. | 50 |
| Sony | Sony Corporation | 42 |
| CuratOR | Eizo Corporation | 38 |
| FSN | Foreseeson Custom Displays, Inc. | 25 |
| ILO | ILO Electronic Gmbh | 25 |
| Camera, Surgical And Accessories | Pentax of America, Inc. | 24 |
| Beacon | Shenzhen Beacon Display Technology Co., Ltd. | 24 |
| Tidishield | Tidi Products, LLC | 22 |
| NDS | Pentax of America, Inc. | 19 |
Showing 12 of 190. All products under Camera, Surgical And Accessories
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Barco N.V. | UDI-DI | 2023-12-20 | Class II | Under Investigation by firm | Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked. | 2 units |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-05-28 | Class II | Process design | User settings were no longer on the monitor’s memory after these systems were powered off and back on. | 462 devices in US | 2017-03-09 |
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.