Anrei Medical (HangZhou) CO., Ltd.
HANGZHOU Zhejiang, CN
Anrei Medical (HangZhou) CO., LTD. appears in FDA device records in HANGZHOU Zhejiang, CN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Anrei Medical (HangZhou) CO., Ltd. between 2020 and 2022. The busiest year on record is 2021, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212999 | Multi-Functional Electrosurgical Knife | KNS | Substantially Equivalent | |
| K210917 | Single Use Injection Needle | FBK | Substantially Equivalent | |
| K202987 | Rescue Pulmonary Grasping Forceps | EOQ | Substantially Equivalent | |
| K210660 | Stone Retrieval Balloon Catheter | GCA | Substantially Equivalent | |
| K201771 | Single Use Rotatable and Repositionable Hemoclip | PKL | Substantially Equivalent | |
| K192048 | Single Use Endoscope Valves Set | ODC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006621103 | 3006621103 | Anrei Medical (Hangzhou) Co., Ltd. | NO. 3 AVE. 8, HEDA HANGZHOU, HANGZHOU Zhejiang 310018 CN | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- EOQBronchoscope (Flexible Or Rigid)
- ODCEndoscope Channel Accessory
- MNKEndoscopic Bite Block
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- FCLForceps, Biopsy, Non-Electric
- PKLHemostatic Metal Clip For The Gi Tract
- GAESnare, Surgical
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain