Alton Shanghai Medical Instruments Co Ltd
Manufacturer and brand owner in Shanghai, China. 20 device types, 5 products catalogued, 6 clearances.
Alton Shanghai Medical Instruments Co Ltd is a complaint-file establishment holding a current FDA establishment registration. The registration covers Stent, Ureteral, Ligator, Esophageal and 18 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
20device types registered with the FDA
5products catalogued under its own name
6510(k) clearances
Registration
| Registered name | ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008797804 |
| FEI number | 3008797804 |
| DUNS | 527128502 |
| Establishment type | Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 上海埃尔顿医疗器械有限公司 |
|---|---|
| Unified social credit code | 91310106771478053L |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No.24 Building Jinshao Rd.1688.Baoshan District |
| Postal code | 200949 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | Disposable Cleaning Brush, Reusable Cleaning Brush, Port Hole Cleaning Brush | 2011 | 43 |
| Attachment, Teaching, For Endoscope | Class 1 | Valve Cap | 2026 | 2 |
| Biliary Catheter For Irrigation And Contrast Injection, Exempt | Class 2 | Biliary Plastic Stent | 2026 | 1 |
| Bottle, Collection, Vacuum | Class 2 | Disposable Drainage Collection device | 2022 | 88 |
| Bronchoscope Accessory | Class 2 | Disposable Cytology Brush (AF series) | 2025 | 5 |
| Colonoscope And Accessories, Flexible/Rigid | Class 2 | 2025 | 9 | |
| Device, Measuring, For Panendoscope | Class 1 | Disposable measuring Ruler | 2026 | 1 |
| Endoscope Channel Accessory | Class 2 | 2025 | 21 | |
| Endoscopic Bite Block | Class 1 | Bite Blocks | 2011 | 44 |
| Endoscopic Cytology Brush | Class 2 | Disposable Cytology Brush (AF series) | 2025 | 5 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | Retrieval Basket, Disposable Grasping Forceps, Polyp Trap | 2022 | 21 |
| Endoscopic Guidewire, Gastroenterology-Urology | Class 2 | Disposable Guidewire | 2023 | 21 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | Disposable Injection Needle | 2023 | 23 |
| Forceps, Biopsy, Non-Electric | Class 1 | Disposable Biopsy Forceps | 2011 | 44 |
| Gastroscope And Accessories, Flexible/Rigid | Class 2 | 2025 | 9 | |
| Hemostatic Metal Clip For The Gi Tract | Class 2 | Disposable Hemoclip | 2024 | 17 |
| Ligator, Esophageal | Class 2 | Multi-Band Ligator | 2023 | 7 |
| Ligator, Hemorrhoidal | Class 2 | Ligation device, Disposable hemorrhoid ligation | 2023 | 12 |
| Snare, Non-Electrical | Class 1 | Disposable cold snare | 2011 | 19 |
| Stent, Ureteral | Class 2 | 2025 | 4 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243039 | 2025-06-18 | FAD | Traditional | This company |
| K242635 | 2025-05-30 | FDS | Traditional | This company |
| K241679 | 2025-03-04 | KTI | Traditional | This company |
| K241285 | 2024-10-01 | ODC | Traditional | This company |
| K231633 | 2024-01-11 | PKL | Traditional | This company |
| K230925 | 2023-09-27 | FBK | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | GI endoscopy consumables, Respiratory endoscopy consumables, Urology consumables, Disposable electronic endoscopes |
| Certifications | ISO 13485, EU 93/42 EEC, FDA |
| Export markets | 80+ countries globally |
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.