FDA Registration
Active
🇨🇳 China
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3013460719
·
FEI: 3013460719
·
Expires 2026
Products
27
Proprietary Names
23
Establishment Types
3
Classifications
27
Registration Details
- Registration Name
- ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3013460719
- FEI Number
- 3013460719
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 101-1, 201-1, 301, 401, Building 50, No.650 Hongfeng Road, Donghu Street, Linping District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212668
Owner / Operator
- Firm Name
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- Operator Number
- 10053736
- Address
- Room 101-1, 201-1, 301, 401, Building 50, No.650 Hongfeng Road, Donghu Street, Linping District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311100
- Country
- CN
- Correspondent
- Lucius Long
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2022-03-01 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2017-02-22 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2019-03-06 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2023-05-17 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2019-03-06 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2023-09-22 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2023-09-22 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2020-08-23 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2022-06-01 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2017-01-05 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2017-02-08 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2018-04-02 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2019-12-30 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2022-08-01 |
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2017-04-25 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2026-03-09 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2019-03-06 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2018-04-02 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2020-01-06 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2020-01-06 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2017-02-08 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2020-04-03 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2021-07-15 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2026-03-01 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2017-04-25 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2017-04-25 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2023-05-17 |
Proprietary Names
Sclerotherapy Needle
Polyp Trap
Single Use Grasping Forceps
Single Use Urethral Dilator
Single Use Guidewire/Single Use Urinary Guidewire
Air/Water Bottle Tubing, CO2 Source Tubing
Chuangxiang
Single Use Ureteral Access Sheath
Cleaning Brush
Single Use Biopsy Forceps
Single Use Hemoclip
Disposable Valve Sets; MD-A-AW01; MD-B-AW01; Sterilization, endoscopic Compatibility:Olympus 140/160/180/190/240/260
Single Use Cytology Brush
Single Use Retrieval Snare Net, Cold Snare
Disposable Biopsy Valve
Single use stone retrieval balloons
Rotatable Snares, Non-Rotatable Snares
In-Sight Multi-Band Ligator
Disposable Bite Block
Colonoscopy holding device
Disposable Ureteral Stents (Types C and D)
Endoscopy Irrigation Tubing
Single Use Urinary Stone Retrieval Basket
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device