Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011181002

FEI Number

3011181002

Entity Name

Sorin Group DR S.r.l.

City/State/Country

Santo Domingo, DO

Establishment Address

Zona Franca Industrial de Las Americas,, Nave I-3 Km. 22 Autopista Las Americas, Santo Domingo 11606, DO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MicroPort CRM USA, Inc. (Owner Number: 2182863)

Owner / Operator Contact Address

5677 Airline Road, Regulatory Affairs, c/o Dwyndl Nelms, Arlington, TN 38002, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P130010

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2023-06-13

Official Correspondent

John Skousen

US Agent Details

John Skousen Business: MICROPORT CRM USA, INC. Email: john.skousen@crm.microport.com Phone: (801) 3864437

Related Public Records

Same Entity

MicroPort CRM USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008159616	Sorin CRM SAS	CLAMART Hauts-de-Seine, FR

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3008973940	Medtronic Singapore Operations Pte Ltd	Singapore Central Singapore, SG
2649622	MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA	Villalba, PR, US
3009380063	Medtronic Distribution Center	Memphis, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011181002. Last updated year: 2026. Please use registration number 3011181002 when referencing this establishment in official correspondence.