BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    SORIN GROUP ITALIA S.R.L

    Reg #: 9680841 · FEI: 3005426550 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    190
    Establishment Types
    2
    Classifications
    17

    Registration Details

    Registration Name
    SORIN GROUP ITALIA S.R.L
    Registration Number
    9680841
    FEI Number
    3005426550
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    86, VIA STATALE 12 NORD
    City
    MIRANDOLA Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K120185

    Owner / Operator

    Firm Name
    SORIN GROUP ITALIA S.R.L
    Operator Number
    9011842
    Address
    86, VIA STATALE 12 NORD, --
    City
    MIRANDOLA (MO)
    State
    Modena
    Postal Code
    41037
    Country
    IT
    Correspondent
    LUIGI - VECCHI

    Products

    Device Name Product Code
    Oxygenator, Cardiopulmonary Bypass DTZ
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Apparatus, Autotransfusion CAC
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Defoamer, Cardiopulmonary Bypass DTP
    Cannula, Catheter DQR
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Dual Lumen Ecmo Cannula PZS
    Console, Heart-Lung Machine, Cardiopulmonary Bypass DTQ
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Sleeve, Limb, Compressible JOW
    Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS
    Accessory Equipment, Cardiopulmonary Bypass KRI

    Proprietary Names

    INSPIRE 6F INSPIRE 6F M INSPIRE HVR D733 MICRO 40 Ph.I.S.I.O. D731 MICRO 27 Ph.I.S.I.O. COD. 151 COD. 150 Femoral arterial cannula set 17 fr INSPIRE 8M INSPIRE 8 Dual Stage Venous Return Cannulae CSC14 XTRA Sequestration and Collection sets SMARxT BCD Vanguard System KIDS D101 KIDS D100 KIDS D101 M KIDS D100 M Protek Duo 31 Fr Mini Femoral arterial cannula set 15 Fr D734 MICRO 40 D732 MICRO 27 Revolution MICRO Arterial Filters INSPIRE 8 DUAL INSPIRE HVR DUAL INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir INSPIRE 7F M oxgenator with integrated arterial filter INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir INSPIRE 6 DUAL INSPIRE 6F DUAL INSPIRE 6M D920, Lilliput 1 twin reservoir Ventricular Vent Catheter (VT-XXXXX) Coronary Sinus Cannula (RCM-XXXXX) XTRA Bowl sets Revolution PC D736 MICRO 40 D735 MICRO 20 Femoral arterial cannula set 14 fr D131 Ph.I.S.l.O. Dideco Kids D734 MICRO 40 Ph.I.S.I,O. Transeptal cannula set EF 72 Venous Cardiopolmunary Bypass Cannula (RV-XXXXX) A272-xx Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae A211-xx A/B/C/D/E/F/N series A232-xx D/E/F series A262-xx A/B/C/D/E/F series A222-xx A/B/C/D/E/F/N series A212-73 A/B/C/D/E/F A212-xx A/B/C/D/E/F/N series LINEA ASPIRAZIONE XTRA PROCEDURE SET TX/175 PROCEDURE SET TX/125 BOWL SET X/225 PROCEDURE SET TX/225 PROCEDURE SET BX/125 BOWL SET X/125 BOWL SET X/175 PROCEDURE SET BX/225 PROCEDURE SET TX/55 PROCEDURE SET BX/55 PROCEDURE SET BX/175 BOWL SET X/55 XTRA Autotransfusion Cell Separator XRES T with preconnected cardio kit COLLECTION SET BX CARDIO SEQUESTRATION SET X COLLECTION SET TX CARDIO COLLECTION SET TX COLLECTION SET BX V122-xx BMR1900 SMARxT Protek venous dilator set D762 D752 D754 D764 D100 DIDECO KIDS M PHISIO D120 DIDECO KIDS R PHISIO D100 DIDECO KIDS PHISIO KIDS Arterial Filters BMR1900 Phisio Protek Duo 31 Fr Protek Duo 29 Fr Preotek Duo 31 Fr RD XRES T XRES B INSPIRE 8F DUAL INSPIRE 8F M V38SAT V12SAT BRAT 2 processing sets Reservoir Outlet Clamp Coronary Sinus Cannula (RCS-XXXXX) B-Capta P615-xx P607-xx P608-xx P606-xx P605-xx P616-xx P617-xx P618-xx CARD 43 Cardioplegia Cannula (VC/AR/AX - XXXXX) INSPIRE 8F Vanguard Blood Cardioplegia Systems R502-xx R501-xx D732 MICRO 27 PH.I.S.I.O. Inspire HCR cardiotomy reservoir Inspire HCR DUAL cardiotomy reservoir D101 DIDECO KIDS PHISIO D101 DIDECO KIDS M PHISIO D121 DIDECO KIDS R PHISIO EOS PMP EOS PMP INTEGRATED Cardiotomy reservoir without filter Cardiotomy reservoir with filter INSPIRE SVR 1200 A232-xx A/B/C/N series A221-xx A/B/C/D/E/F/N series A261-xx A/B/C/D/E/F/N series A231-xx A/B/C/D/E/F/N series DHF 0.6 DHF 0.2 ProtekDilate Vascular Access Kit TANDEM RESERVOIR "Y" Electa WS-125E WS-225E WS-175E WS-55E INSPIRE 7 INSPIRE 7 DUAL INSPIRE 7 M Hemoconcentrators D903 AVANT HOLLOW FIBER OXYGENATOR D970 DIDECO AVANT RESERVOIR INSPIRE 6 WCB-10 D130 Ph.I.S.I.O. Dideco Kids R501-R502 aortic root cannulae D731 MICRO 27 D733 MICRO 40 NGBCD8C NGBCD1 NGBCDP NGBCD4 NGBCD8 NGBCD2 NGBCD4C Protek Solo 24 FR S353-50 S361-50 S352-80 S351-70 S354-25 Transeptal cannula set EF62 Cardiopolmunary Bypass Cannula (EasyFlow) V162-xx V112-xx V132-xx V113-xx V111-xx V152-xx A272-40 Femoral Venous Cannula (RAP) Arterial Cannula Holders Brackets RV-XXXXX SH 14 BRB-1 Synergy MIMESYS IDEAL MIMESYS PureFlex Arterial Cannulae OEL AAL VEL CYA DEC DAC D744 DAC D742 DAC D740 W420-62 W410-62 BMR1900 phisio closed venous reservoir bag

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility