Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

24.09.2026 09:07

Sync status

Successful

Device

3605996

Actor

47869

Certificate

3406

Active filter:Manufacturer SRN:US-MF-000019976

29 device results listed.

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00763000923570

HeartWare HVAD System

Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923570
Basic UDI-DI
0763000B000092489
Reference
1450
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
Netherlands
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:59
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923853
Basic UDI-DI
0763000B000092489
Reference
MCS1622PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:54
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923808
Basic UDI-DI
0763000B000092489
Reference
MCS1622PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:54
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923877
Basic UDI-DI
0763000B000092489
Reference
MCS1622PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:54
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923686
Basic UDI-DI
0763000B000092489
Reference
2060
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:54
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000989514
Basic UDI-DI
0763000B000092489
Reference
MCS1421CN
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:54
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923815
Basic UDI-DI
0763000B000092489
Reference
MCS1622PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:54
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923693
Basic UDI-DI
0763000B000092489
Reference
1750
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:54
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923839
Basic UDI-DI
0763000B000092489
Reference
MCS1622PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:54
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923754
Basic UDI-DI
0763000B000092489
Reference
MCS1621PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923846
Basic UDI-DI
0763000B000092489
Reference
MCS1622PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923723
Basic UDI-DI
0763000B000092489
Reference
MCS1621PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923785
Basic UDI-DI
0763000B000092489
Reference
MCS1621PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923884
Basic UDI-DI
0763000B000092489
Reference
MCS1728ST
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923860
Basic UDI-DI
0763000B000092489
Reference
MCS1622PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923747
Basic UDI-DI
0763000B000092489
Reference
MCS1621PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923761
Basic UDI-DI
0763000B000092489
Reference
MCS1621PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923822
Basic UDI-DI
0763000B000092489
Reference
MCS1622PC
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
24.09.2026 02:53
00763000923563

HeartWare HVAD System

Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923563
Basic UDI-DI
0763000B000092489
Reference
1440
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
Netherlands
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
23.09.2026 20:02
Class IIIMDR 2017/745On the marketActive deviceImplantable
Manufacturer
HeartWare, Inc.
Manufacturer SRN
US-MF-000019976
UDI-DI
00763000923679
Basic UDI-DI
0763000B000092489
Reference
2050
EMDN
J01030102
EMDN description
IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
First on market country
-
Safety summary (SSCP/SSP)
SSCP004 · Rev. 11
Authorised representative
Medtronic B.V.
Last updated
23.09.2026 18:40