Hysteroscope (And Accessories)
Cystoscope, Autoclavable, with Integrated Green Light Filter, 30 ¿ View Direction
13manufacturers in China registered for this device type
42catalogue 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HIH |
| Device type | Hysteroscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1690 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2022-11-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Outer diameter 2.9 to 4 mm; length 41 to 115 cm |
| Distribution end date | 2022-11-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0502270590 | Degree: 90.0 Degree | In distribution |
| 0502990322 | In distribution | |
| 0502880601 | In distribution | |
| 0502880401 | In distribution | |
| 0502991000 | Outer Diameter 4.0 mm | In distribution |
| 0502880219 | In distribution | |
| 0502740030 | Outer Diameter 4.0 mm | In distribution |
| 0502991030 | Outer Diameter 4.0 mm | In distribution |
| 0502729052 | Outer Diameter 2.9 mm | In distribution |
| 0502880002 | In distribution | |
| 0502990030 | Outer Diameter 4.0 mm | In distribution |
| 0502880502 | In distribution | |
| 0502740000 | Outer Diameter 4.0 mm | In distribution |
| 0502880425 | In distribution | |
| 0502990324 | In distribution | |
| 0502777300 | Length 41.0 cm | In distribution |
| 0502880210 | In distribution | |
| 0502991070 | Outer Diameter 4.0 mm | In distribution |
| 0505880115 | In distribution | |
| 0502990012 | Outer Diameter 4.0 mm | In distribution |
| 0502880426 | In distribution | |
| 0502270400 | In distribution | |
| 0502532030 | Outer Diameter 4.0 mm | In distribution |
| 0502880214 | Degree: 70.0 Degree | In distribution |
| 0502777200 | Length 41.0 cm | In distribution |
| 0502880201 | In distribution | |
| 0502991012 | Outer Diameter 4.0 mm | In distribution |
| 0502740050 | In distribution | |
| 0502555200 | Length 41.0 cm | In distribution |
| 0502880524 | In distribution | |
| 0502990070 | Outer Diameter 4.0 mm | In distribution |
| 0502880200 | In distribution | |
| 0502880006 | In distribution | |
| 0502880225 | In distribution | |
| 0502990300 | In distribution | |
| 0502270200 | In distribution | |
| 0502880215 | Degree: 30.0 Degree | In distribution |
| 0502990000 | Outer Diameter 4.0 mm | In distribution |
| 0502220500 | In distribution | |
| 0502740012 | Outer Diameter 4.0 mm | In distribution |
| 0504833115 | Length 115.0 cm | Withdrawn |
| 0502023027 | Withdrawn |
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 |
| TruClear | Covidien LP | 29 |
| Hysteroscopy sheath | Sopro-Comeg GmbH | 28 |
| 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.