Hysteroscopy Sheath
28 catalogue numbers from 191 273 052BC, listed by Sopro-Comeg GmbH, Germany, under Hysteroscope (And Accessories). 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (4), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Ningbo Skonsin Electronics Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Shanghai AnQing Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Guangdong EO Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Suzhou Acuvu Medical Technology Co., Ltd. | Suzhou | Jiangsu | Specification developer | 4 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
Showing 12 of 13. All 13 manufacturers in China registered for Hysteroscope (And Accessories)
Record
| Listed by | Sopro-Comeg GmbH, Germany |
|---|---|
| FDA product code | HIH |
| Device type | Hysteroscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1690 |
| 510(k) | K945265 |
| Record published | 2016-12-22 |
| Record revised | 2019-03-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 191 273 052BC | In distribution | |
| 191 202 470BC | In distribution | |
| 191 293 052BC | In distribution | |
| 191 273 052 | In distribution | |
| 191 403 072 | In distribution | |
| 191 202 470 | In distribution | |
| 191 273 050 | In distribution | |
| 191 403 102BC | In distribution | |
| 191 203 050 | In distribution | |
| 191 203 060 | In distribution | |
| 191 273 202 | In distribution | |
| 191 273 050BC | In distribution | |
| 191 293 052 | In distribution | |
| 191 203 060BC | In distribution | |
| 191 423 072 | In distribution | |
| 191 273 100BC | In distribution | |
| 191 273 202BC | In distribution | |
| 191 203 050BC | In distribution | |
| 191 273 102BC | In distribution | |
| 191 273 100 | In distribution | |
| 191 273 102 | In distribution | |
| 191 403 070BC | In distribution | |
| 191 403 100BC | In distribution | |
| 191 403 102 | In distribution | |
| 191 403 070 | In distribution | |
| 191 403 072BC | In distribution | |
| 191 403 100 | In distribution | |
| 191 423 072BC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hysteroscope (And Accessories) | Karl Storz GmbH & Co. KG | 255 |
| AED | National Advanced Endoscopy Devices, Inc. | 79 |
| USA Elite | Gyrus Acmi, Inc. | 79 |
| Olympus | Olympus Winter & IBE Gmbh | 57 |
| Hysteroscope (And Accessories) | Stryker GmbH | 42 |
| TruClear | Covidien LP | 29 |
| Hysteroscope (And Accessories) | Richard Wolf Gmbh | 24 |
| Hysteroscope | Sopro-Comeg GmbH | 18 |
| Elite 2 System | Gyrus Acmi, Inc. | 17 |
| Gynecare Versapoint | Ethicon, Inc. | 16 |
| USA Elite System | Gyrus Acmi, Inc. | 11 |
| SlimLine | Gyrus Acmi, Inc. | 10 |
Showing 12 of 177. All products under Hysteroscope (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.