FDA Registration
Active
🇨🇳 China
Anrei Medical (HZ) CO., LTD.
Reg #: 3006621103
·
FEI: 3006621103
·
Expires 2026
Products
12
Proprietary Names
19
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- Anrei Medical (HZ) CO., LTD.
- Registration Number
- 3006621103
- FEI Number
- 3006621103
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 3 AVE. 8, HEDA HANGZHOU, CHINA
- City
- HANGZHOU Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202987
Owner / Operator
- Firm Name
- ANREI MEDICAL (HZ) CO., LTD.
- Operator Number
- 9106461
- Address
- NO. 3, AVE. 8, HEDA HANGZHOU, CHINA
- City
- HANGZHOU
- State
- Zhejiang
- Postal Code
- 310018
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2018-02-06 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2018-07-17 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2021-04-29 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2021-05-31 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2013-01-17 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2018-02-06 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2021-07-12 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2007-08-29 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2020-10-20 |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | Class 2 | Gastroenterology, Urology | No | 2021-04-27 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2022-04-04 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2020-05-15 |
Proprietary Names
Single-use Bite Block
VersaGraspTM Single-Use Grasping Forceps
Single-Use Grasping Forceps
single use stone retrieval basket/single use retrieval basket
Endoscopic Grasping Forceps
Pulmonary Grasping Forceps
Single Use Injection Needle
RatTooth Grasping Forceps
RatTooth/Alligator Grasping Forceps
Alligator Grasping Forceps, Long
Alligator Grasping Forceps
RatTooth Grasping Forceps-Pediatric
Single-use Guide Wire
Single-use Cold Snare/Cold Snare
SINGLE-USE BIOPSY FORCEPS
Single Use Rotatable and Repositionable Hemoclip/Hemostatic Clip
Stone Retrieval Balloon Catheter
Multi-Functional Electrosurgical Knife
Single Use Endoscope Valves Set
Establishment Types
Manufacture Medical Device