Video Colposcope
2 catalogue numbers from C6A, listed by Edan Instruments, Inc., China, under Colposcope (And Colpomicroscope). 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangxi (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Goldcare Meditech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| Beijing Tech Instrument Co., Ltd. | Chongwen District | Beijing | Manufacturer | 1 |
Record
| Listed by | Edan Instruments, Inc., China |
|---|---|
| FDA product code | HEX |
| Device type | Colposcope (And Colpomicroscope) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1630 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2016-09-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C6A | In distribution | |
| C3A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leisegang | Coopersurgical, Inc. | 17 |
| Microscope Colposcope | Ecleris SRL | 16 |
| Bovie | Aspen Surgical Products, Inc. | 15 |
| Henry Schein | Henry Schein, Inc. | 15 |
| Galileo Colposcope, Direct Access | Gynex Corporation | 11 |
| Microstar Colposcope | Ecleris SRL | 11 |
| Wallach | Coopersurgical, Inc. | 7 |
| Kernel | Xuzhou Kernel Medical Equipment Co Ltd | 6 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Unico ColpoMaster I | United Products & Instruments, Inc. | 4 |
| Gynex | Gynex Corporation | 4 |
| medgyn video colposcope | Medgyn Products, Inc. | 3 |
Showing 12 of 42. All products under Colposcope (And Colpomicroscope)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151878 | 2015-12-01 |
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.