FDA Registration
Active
🇮🇪 Ireland
SurVeil Drug-Coated Balloon
Reg #: 3005994106
·
FEI: 3005994106
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Creagh Medical Ltd.
- Registration Number
- 3005994106
- FEI Number
- 3005994106
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- IDA Business Park, Ballinasloe
- City
- Co. Galway
- Country
- IE
Regulatory Submissions
- PMA Number
- P210025
Owner / Operator
- Firm Name
- Surmodics, Inc
- Operator Number
- 10023361
- Address
- 9924 W 74th street
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
US Agent
- Business Name
- Surmodics
- Contact Name
- Carla Erickson
- Address
- 9924 West 74th Street
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
- [email protected]
- Phone
- 952 5007258
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | Class 3 | Unknown | No | 2023-08-09 |
Proprietary Names
SurVeil Drug-Coated Balloon
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)