Hangzhou AGS MedTech Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 19 device types, 16 products catalogued, 19 clearances.
Hangzhou AGS MedTech Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Snare, Flexible, Dilator, Esophageal and 17 other device types. 16 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010288205 |
| FEI number | 3010288205 |
| DUNS | 542984702 |
| Establishment type | Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 杭州安杰思医学科技股份有限公司 |
|---|---|
| Unified social credit code | 913301105660667546 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Building 2,5 and 7, No.389 Xingzhong Road |
| Postal code | 311103 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Forceps, Biopsy, Non-Electric | FCL | 384 |
| Hemostatic Metal Clip For The Gi Tract | PKL | 368 |
| Snare, Non-Electrical | FGX | 262 |
| Snare, Flexible | FDI | 125 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | 106 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 90 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 73 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 38 |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | 24 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 21 |
| Forceps, Biopsy, Electric | KGE | 12 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | 10 |
| Dislodger, Stone, Biliary | LQR | 4 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | 4 |
| Endoscopic Irrigation/Suction System | OCX | 1 |
| Endoscope Channel Accessory | ODC | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254069 | 2026-08-10 | PKL | Traditional | This company |
| K253393 | 2026-06-24 | FGE | Traditional | This company |
| K252270 | 2026-04-08 | PKL | Traditional | This company |
| K252271 | 2025-11-12 | PKL | Traditional | This company |
| K241704 | 2025-03-20 | OCX | Traditional | This company |
| K222421 | 2023-05-03 | KNS | Traditional | This company |
| K221713 | 2023-03-03 | FDI | Traditional | This company |
| K213143 | 2022-07-12 | PKL | Traditional | This company |
| K213578 | 2022-04-06 | FDF | Traditional | This company |
| K211787 | 2022-03-03 | PKL | Traditional | This company |
| K210406 | 2021-10-05 | KGE | Traditional | This company |
| K201121 | 2021-02-05 | KNS | Traditional | This company |
| K202237 | 2020-12-23 | ODC | Traditional | This company |
| K201509 | 2020-12-16 | LQR | Traditional | This company |
| K192342 | 2020-05-21 | KNS | Traditional | This company |
| K200173 | 2020-05-01 | GCA | Traditional | This company |
| K190032 | 2020-02-27 | FBK | Traditional | This company |
| K172729 | 2018-05-21 | FDI | Traditional | This company |
| K172727 | 2018-04-16 | PKL | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Employees | 744 |
| Main products | endoscopic minimally invasive devices, ERCP devices, diagnostic instruments |
| Certifications | National high-tech enterprise, GMP |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.