Andorate® 3-Piece Valve Kit
7 catalogue numbers from 101037, listed by GA Health Company Limited, Hong Kong, under Endoscope Channel Accessory. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
7catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (7), Shanghai (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
Showing 12 of 21. All 21 manufacturers in China registered for Endoscope Channel Accessory
Record
| Listed by | GA Health Company Limited, Hong Kong |
|---|---|
| FDA product code | ODC |
| Device type | Endoscope Channel Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2026-02-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 50, carton of 8, carton of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101037 | In distribution | |
| 101004 | In distribution | |
| 101065 | In distribution | |
| 101087 | In distribution | |
| GAR037P | In distribution | |
| GAR037 | In distribution | |
| GAR087 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CeroFrict | SML MED-Tech Solutions Limited | 60 |
| Disposable Endoscopy Adapter Sets | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 14 |
| andorate® Biopsy Valve | GA Health Company Limited | 8 |
| andorate® 4-piece Valve Kit | GA Health Company Limited | 8 |
| Cook | Cook Incorporated | 7 |
| Water Jet Adapter | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 7 |
| Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit | GA Health Company Limited | 7 |
| Defendo Single Use Valve Kit | Medivators Inc | 6 |
| Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory) | 6 |
| Andorate | Smartdata Suzhou Co., Ltd. | 6 |
| BullDog® | Diversatek Healthcare Inc | 6 |
| Disposable Endoscopy Adapter Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 6 |
Showing 12 of 89. All products under Endoscope Channel Accessory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232118 | 2023-10-16 |
| K213095 | 2022-01-12 |
| K200495 | 2020-06-24 |
| K200481 | 2020-06-18 |
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.