Microstar Colposcope
Colposcope w/ Floor Stand, Pantographic Arm & Straight Binocular
4manufacturers in China registered for this device type
11catalogue numbers in this listing
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 | Ecleris SRL, Argentina |
|---|---|
| FDA product code | HEX |
| Device type | Colposcope (And Colpomicroscope) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1630 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K100595 |
| Record published | 2023-08-22 |
| Record revised | 2026-02-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -30 to 45 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment humidity 35 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R02 | In distribution | |
| R00 | In distribution | |
| R00 | In distribution | |
| R01 | In distribution | |
| R01 | In distribution | |
| R00 | In distribution | |
| RX1 | In distribution | |
| R00 | In distribution | |
| R00 | In distribution | |
| R00 | In distribution | |
| R00 | 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 |
| 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 |
| MedGyn Gynescope | Medgyn Products, Inc. | 3 |
Showing 12 of 42. All products under Colposcope (And Colpomicroscope)
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.