Olympus
9 catalogue numbers from A4833, listed by Olympus Winter & IBE Gmbh, Germany, under Hysteroscope Accessories. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Guangdong (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Suzhou Acuvu Medical Technology Co., Ltd. | Suzhou | Jiangsu | Specification developer | 4 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
| Origyn Medical Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Specification developer | 2 |
Record
| Listed by | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | NWW |
| Device type | Hysteroscope Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1690 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-01-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4833 | In distribution | |
| A4828 | In distribution | |
| A4825 | In distribution | |
| A4827 | In distribution | |
| A4832 | In distribution | |
| A4829 | In distribution | |
| A4830 | In distribution | |
| A4831 | In distribution | |
| A4824 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 55 |
| OriGynMED | Origyn Medical Technology (Hangzhou) Co., Ltd. | 36 |
| Elmed | Elmed, Inc. | 33 |
| Strauss Surgical | American Medical Endoscopy | 16 |
| Clickline | Karl Storz GmbH & Co. KG | 9 |
| Hysteroscope Accessories | Karl Storz GmbH & Co. KG | 8 |
| Hysteroscope Accessories | Henke-Sass Wolf, Gmbh. | 7 |
| Elmed Incorporated | Elmed, Inc. | 6 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 5 |
| Hysteroscope Accessories | Boston Scientific Corporation | 4 |
| Pneumostop® | LSI Solutions Inc. | 4 |
| Single-use Endoscopic Scissors | Macrolux Medical Technology Co., Ltd. | 3 |
Showing 12 of 50. All products under Hysteroscope 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.