Data / Medical devices / China / Anrei Medical (Hangzhou) Co., Ltd.
Anrei Medical (Hangzhou) Co., Ltd.: FDA-registered device maker in HANGZHOU Zhejiang, China, 8 510(k) clearances
Anrei Medical (Hangzhou) Co., Ltd. is registered with the FDA (registration 3006621103) in HANGZHOU Zhejiang, China. It lists 12 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 2, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006621103
- Address
- No. 3 Ave. 8, Heda Hangzhou China, HANGZHOU Zhejiang, China, 310018
- Owner or operator
- Anrei Medical (Hangzhou) Co., Ltd. (9106461)
- Roles
- Manufacturer
- First device listed
- August 29, 2007
- Registered through
- 2027
- Brand names listed
- Alligator Grasping Forceps, Alligator Grasping Forceps, Long, Endoscopic Grasping Forceps, Hemostatic Clip, Multi-Functional Electrosurgical Knife, Pulmonary Grasping Forceps, RatTooth Grasping Forceps, RatTooth Grasping Forceps-Pediatric and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | 2 | Manufacturer | accessdata.fda.gov |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Manufacturer | accessdata.fda.gov |
| Hemostatic Metal Clip For The Gi Tract | PKL | 2 | Manufacturer | accessdata.fda.gov |
| Snare, Surgical | GAE | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2026 | K261741 | Hemostatic Clip | PKL | Substantially Equivalent | Anrei Medical (Hz) Co., Ltd. | accessdata.fda.gov |
| March 21, 2022 | K212999 | Multi-Functional Electrosurgical Knife | KNS | Substantially Equivalent | Anrei Medical (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| May 28, 2021 | K210917 | Single Use Injection Needle | FBK | Substantially Equivalent | Anrei Medical (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| April 29, 2021 | K202987 | Rescue Pulmonary Grasping Forceps | EOQ | Substantially Equivalent | Anrei Medical (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| April 27, 2021 | K210660 | Stone Retrieval Balloon Catheter | GCA | Substantially Equivalent | Anrei Medical (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| October 19, 2020 | K201771 | Single Use Rotatable and Repositionable Hemoclip | PKL | Substantially Equivalent | Anrei Medical (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| May 14, 2020 | K192048 | Single Use Endoscope Valves Set | ODC | Substantially Equivalent | Anrei Medical (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| August 5, 2010 | K101298 | ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS | OCZ | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Hemostatic Metal Clip For The Gi Tract
- All makers of Endoscope Channel Accessory
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- All makers of Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.