FDA Registration
Active
🇨🇳 China
ZHENDE MEDICAL CO., LTD.
Reg #: 3003348807
·
FEI: 3003348807
·
Expires 2026
Products
14
Proprietary Names
2
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- ZHENDE MEDICAL CO., LTD.
- Registration Number
- 3003348807
- FEI Number
- 3003348807
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GAOBU TOWN
- City
- SHAOXING Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201729
Owner / Operator
- Firm Name
- Zhende Medical Co., Ltd
- Operator Number
- 9050974
- Address
- GAOBU TOWN, --
- City
- SHAOXING, ZHEJIANG PROVINCE
- State
- CN-ZJ
- Postal Code
- 312035
- Country
- CN
- Correspondent
- Ming Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-12-07 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2021-08-10 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2024-04-02 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2009-11-05 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2002-04-29 |
| Cement, Stomal Appliance, Ostomy | EZR | Class 1 | Gastroenterology, Urology | No | 2020-12-08 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2003-07-10 |
| Ostomy Care Kit | PQE | Class 1 | Gastroenterology, Urology | No | 2020-05-28 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2002-08-06 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2021-04-02 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2018-06-05 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2021-01-19 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2017-10-17 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2023-03-14 |
Proprietary Names
Isosafe Earloop Procedure Mask(Blue,Yellow)
Ostomy ring
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device