FDA Registration
Active
🇩🇴 Dominican Republic
Sorin Group DR S.r.l.
Reg #: 3011181002
·
FEI: 3011181002
·
Expires 2026
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- Sorin Group DR S.r.l.
- Registration Number
- 3011181002
- FEI Number
- 3011181002
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zona Franca Industrial de Las Americas,, Nave I-3 Km. 22 Autopista Las Americas
- City
- Santo Domingo
- Country
- DO
Regulatory Submissions
- PMA Number
- P130010
Owner / Operator
- Firm Name
- MicroPort CRM USA, Inc.
- Operator Number
- 2182863
- Address
- 5677 Airline Road, Regulatory Affairs, c/o Dwyndl Nelms
- City
- Arlington
- State
- TN
- Postal Code
- 38002
- Country
- US
- Correspondent
- John - Skousen
US Agent
- Business Name
- MICROPORT CRM USA, INC.
- Contact Name
- John Skousen
- Address
- Regulatory Affairs, C/O John Skousen (Microport Crm), 5677 Airline Rd
- City
- Arlington
- State
- TN
- ZIP
- 38002
- Country
- US
- [email protected]
- Phone
- 801 3864437
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2023-06-13 |
Proprietary Names
VEGA R52
Stylet Kit 52cm for VEGA R52
VEGA R45
Stylet Kit 58cm for VEGA R58
Stylet Kit 45cm for VEGA R45
VEGA R58
Establishment Types
Manufacture Medical Device