Andorate
Disposable Endoscope Valves Set
10manufacturers in China registered for this device type
5catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (3), Chongqing (1). 4 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 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou | Jiangsu | Repacker / relabeller | 13 |
| Chongqing Jinshan Science & Technology (Group) Co., Ltd. | Chongqing | Chongqing | Manufacturer | 4 |
Record
| Listed by | Smartdata Suzhou Co., Ltd., China |
|---|---|
| FDA product code | OCX |
| Device type | Endoscopic Irrigation/Suction System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2019-08-26 |
| Record revised | 2024-07-25 (version 4) |
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 | Carton of 4, outer box of 50, outer box of 100, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GAR081 | In distribution | |
| GAR004C | In distribution | |
| GAR028S | In distribution | |
| GAR046 | In distribution | |
| GAR004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endogator Kit | Medivators Inc | 37 |
| Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 21 |
| Erbe | Erbe Elektromedizin GmbH | 19 |
| Endogator | Medivators Inc | 18 |
| Torrent | Us Endoscopy | 14 |
| ClearCap Distal Attachment | Finemedix | 14 |
| EndoGator Hybrid | Medivators Inc | 13 |
| Endoscopic Irrigation/Suction System | Pentax of America, Inc. | 12 |
| Reveal | Us Endoscopy | 12 |
| Endogator hybrid irrigation tubing | Medivators Inc | 10 |
| Erbeflo® 2 | Erbe Medical, LLC | 9 |
| BullDog® | Diversatek Healthcare Inc | 9 |
Showing 12 of 123. All products under Endoscopic Irrigation/Suction System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191366 | 2019-09-06 |
| K182998 | 2019-04-17 |
| K181509 | 2018-07-06 |
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.