Anrei Medical (Hangzhou) Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 12 device types, 6 clearances.
Anrei Medical (Hangzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Snare, Surgical, Endoscopic Bite Block and 10 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006621103 |
| FEI number | 3006621103 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 安瑞医疗器械（杭州）有限公司 |
|---|---|
| Unified social credit code | 91330101788250960E |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | NO. 3 AVE. 8, HEDA HANGZHOU |
| Postal code | 310018 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Class 2 | Stone Retrieval Balloon Catheter | 2021 | 4 |
| Bronchoscope (Flexible Or Rigid) | Class 2 | Pulmonary Grasping Forceps | 2021 | 21 |
| Endoscope Channel Accessory | Class 2 | Single Use Endoscope Valves Set | 2020 | 21 |
| Endoscopic Bite Block | Class 1 | Single-use Bite Block | 2018 | 44 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Class 2 | RatTooth Grasping Forceps-Pediatric, Alligator Grasping Forceps, Long, RatTooth Grasping Forceps, Alligator Grasping Forceps, RatTooth/Alligator Grasping Forceps | 2013 | 6 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | single use stone retrieval basket/single use retrieval basket, VersaGraspTM Single-Use Grasping Forceps, Endoscopic Grasping Forceps, Single-Use Grasping Forceps | 2018 | 21 |
| Endoscopic Guidewire, Gastroenterology-Urology | Class 2 | Single-use Guide Wire | 2018 | 21 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | Single Use Injection Needle | 2021 | 23 |
| Forceps, Biopsy, Non-Electric | Class 1 | Single-USE Biopsy Forceps | 2007 | 44 |
| Hemostatic Metal Clip For The Gi Tract | Class 2 | Single Use Rotatable and Repositionable Hemoclip/Hemostatic Clip | 2020 | 17 |
| Snare, Surgical | Class 1 | Single-use Cold Snare/Cold Snare | 2021 | 9 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class 2 | Multi-Functional Electrosurgical Knife | 2022 | 7 |
Clearances
6 clearances name Anrei Medical (Hangzhou) Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212999 | 2022-03-21 | KNS | Traditional | This company |
| K210917 | 2021-05-28 | FBK | Traditional | This company |
| K202987 | 2021-04-29 | EOQ | Traditional | This company |
| K210660 | 2021-04-27 | GCA | Traditional | This company |
| K201771 | 2020-10-19 | PKL | Traditional | This company |
| K192048 | 2020-05-14 | ODC | Traditional | This company |
| K101298 | 2010-08-05 | OCZ | Traditional | Endochoice, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Main products | Endoscopic instruments, Biopsy forceps, Guidewires, Gastroenterology devices, Minimally invasive instruments |
| Certifications | FDA, CE, ISO13485 |
| OEM and ODM | Offered |
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.