FDA Registration
Active
🇨🇳 China
CARDIOCYCLE MEDICAL(SUZHOU) CO.,LTD.
Reg #: 3042279517
·
FEI: 3042279517
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
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Registration Details
- Registration Name
- CARDIOCYCLE MEDICAL(SUZHOU) CO.,LTD.
- Registration Number
- 3042279517
- FEI Number
- 3042279517
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 401&501, Building C15, Stage 5, BioBAY, No.21 Chaoqian Road, Suzhou Industrial Park
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K251838
Owner / Operator
- Firm Name
- Cardiocycle Medical(Suzhou) Co.,Ltd.
- Operator Number
- 10094401
- Address
- Unit 401&501, Building C15, Stage 5, BioBAY, No.21 Chaoqian Road, Suzhou Industrial Park
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215000
- Country
- CN
- Correspondent
- Siyu Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-11-26 |
Proprietary Names
CorPass
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device