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

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HeartWare HVAD System

Class IIIMDR 2017/745On the marketActive deviceImplantable

Manufacturer: HeartWare, Inc.
Manufacturer SRN: US-MF-000019976
UDI-DI: 00763000923556
Basic UDI-DI: 0763000B000092489
Reference: 1430
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 10:30

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000738945
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2008X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739119
Basic UDI-DI: 0763000B000204078
Reference: NCSLC27512X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739102
Basic UDI-DI: 0763000B000204078
Reference: NCSLC27508X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000738952
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2012X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000738969
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2015X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000738976
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2020X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000738983
Basic UDI-DI: 0763000B000204078
Reference: NCSLC22506X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000738990
Basic UDI-DI: 0763000B000204078
Reference: NCSLC22508X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739003
Basic UDI-DI: 0763000B000204078
Reference: NCSLC22512X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739010
Basic UDI-DI: 0763000B000204078
Reference: NCSLC22515X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739072
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2520X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:24

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000726928
Basic UDI-DI: 0763000B000204078
Reference: NCEUP5015X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739089
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2527X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739065
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2515X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739041
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2508X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739034
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2506X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739058
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2512X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000739027
Basic UDI-DI: 0763000B000204078
Reference: NCSLC22520X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-MF-000019977
UDI-DI: 00763000738938
Basic UDI-DI: 0763000B000204078
Reference: NCSLC2006X
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: -
Safety summary (SSCP/SSP): D00825880 · Rev. B
Authorised representative: Medtronic B.V.
Last updated: 23.09.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details