Data / Medical devices / Dominican Republic / Sorin Group DR S.r.l.
Sorin Group DR S.r.l.: FDA-registered device maker in Santo Domingo, Dominican Republic, 1 PMA approval
Sorin Group DR S.r.l. is registered with the FDA (registration 3011181002) in Santo Domingo, Dominican Republic. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated May 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011181002
- Address
- Zona Franca Industrial de Las Americas, Nave I-3 Km. 22 Autopista Las Americas, Santo Domingo, Dominican Republic, 11606
- Owner or operator
- MicroPort CRM USA, Inc. (2182863)
- Roles
- Manufacturer
- First device listed
- June 13, 2023
- Registered through
- 2026
- Brand names listed
- Stylet Kit 45cm for VEGA R45, Stylet Kit 52cm for VEGA R52, Stylet Kit 58cm for VEGA R58, VEGA R45, VEGA R52, VEGA R58
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 17, 2023 | P130010 | VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) | NVN | 5 | January 15, 2026 | accessdata.fda.gov |
Compare with other makers
Updated January 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.