FDA Registration
Active
🇨🇳 China
DK Medical Technology Co., Ltd.
Reg #: 3027343398
·
FEI: 3027343398
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- DK Medical Technology Co., Ltd.
- Registration Number
- 3027343398
- FEI Number
- 3027343398
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit301, 303,305 and 311 bioBAY B1 Building, 218 Xinghu Str., Suzhou Industrial Park, Suzhou, Jiangsu, 215123, #5 Building, Xinhong Industrial Park, #9 Suhong West Rd., Suzhou Industrial Park, Suzhou, Jiangsu, 215000
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242254
Owner / Operator
- Firm Name
- DK Medical Technology Co., Ltd.
- Operator Number
- 10087839
- Address
- Unit 301, 303,305 and 311 bioBAY B1 Building, 218 Xinghu Str., Suzhou Industrial Park, Suzhou, Jiangsu, #5 Building, Xinhong Industrial Park, #9 Suhong West Rd., Suzhou Industrial Park, Suzhou, Jiangsu
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215123
- Country
- CN
- Correspondent
- Quan Shi
US Agent
- Business Name
- LLINS TECHNOLOGY INC
- Contact Name
- James Wang
- Address
- 1312 17th St
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 720 2171916
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cutting/Scoring | PNO | Class 2 | Cardiovascular | No | 2025-04-29 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2023-04-17 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2023-04-17 |
Proprietary Names
Peripheral Scoring Balloon Dilatation Catheter
D·Kutting PTA Scoring Balloon Dilatation Catheter
PTA High Pressure Balloon Dilatation Catheter
Establishment Types
Manufacture Medical Device