EndoVue
ZIMMER BIOMET, ENDOVUE PLUS 4K 32", BC-WK32-A1B00 (Zimmer Biomet Distributed, Ref # 84-24-3100)
22manufacturers in China registered for this device type
50catalogue numbers in this listing
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 | NDS Surgical Imaging, LLC., United States |
|---|---|
| FDA product code | KQM |
| Device type | Camera, Surgical And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-11 |
| Record revised | 2025-01-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2022-08-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90X0668 | In distribution | |
| 90K0086 | In distribution | |
| 90K0050 | In distribution | |
| 90K0060 | In distribution | |
| 90K0016 | In distribution | |
| 90X0699 | In distribution | |
| 90K0075 | In distribution | |
| 90K0101 | In distribution | |
| 90X0723 | In distribution | |
| 90X0622 | In distribution | |
| 90K0070 | In distribution | |
| 90X0725 | In distribution | |
| 90K0089 | In distribution | |
| 90X0708 | In distribution | |
| 90X0726 | In distribution | |
| 90X0698 | In distribution | |
| 90X0700 | In distribution | |
| 90X0712 | In distribution | |
| 90X0677 | In distribution | |
| 90K0080 | In distribution | |
| 90K0015 | In distribution | |
| 90X0676 | In distribution | |
| 90K0098 | Withdrawn | |
| 90K0074 | Withdrawn | |
| 90K0053 | Withdrawn | |
| 90K0083 | Withdrawn | |
| 90K0063 | Withdrawn | |
| 90K0100 | Withdrawn | |
| 90K0051 | Withdrawn | |
| 90K0085 | Withdrawn | |
| 90K0010 | Withdrawn | |
| 90K0088 | Withdrawn | |
| 90K0066 | Withdrawn | |
| 90K0064 | Withdrawn | |
| 90K0097 | Withdrawn | |
| 90X0532 | Withdrawn | |
| 90K0092 | Withdrawn | |
| 90K0073 | Withdrawn | |
| 90K0091 | Withdrawn | |
| 90K0065 | Withdrawn | |
| 90K0071 | Withdrawn | |
| 90K0081 | Withdrawn | |
| 90K0099 | Withdrawn | |
| 90K0087 | Withdrawn | |
| 90K0076 | Withdrawn | |
| 90K0061 | Withdrawn | |
| 90K0055 | Withdrawn | |
| 90K0090 | Withdrawn | |
| 90K0102 | Withdrawn | |
| 90X533 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Radiance | NDS Surgical Imaging, LLC. | 129 |
| Accu-Beam | Transamerican Technologies International | 114 |
| Barco | Barco, Inc | 89 |
| Conmed | ConMed Corporation | 59 |
| 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
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.