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Class IIIMDR 2017/745Not intended for EU marketNo EU rep

Manufacturer: Medtronic, Inc.
Manufacturer SRN: US-PR-000014548
UDI-DI: 00199309001495
Basic UDI-DI: 0763000B000100773
Reference: TH91SCSP
EMDN: J020780
EMDN description: NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:46

Manufacturer products View details

Barostim™ Programmer System

9020

Class IIIMDR 2017/745On the marketActive device

Manufacturer: CVRx, Inc.
Manufacturer SRN: US-MF-000001082
UDI-DI: 00859144004494
Basic UDI-DI: 00859144004593JQ
Reference: 100067-201
EMDN: J020701
EMDN description: NEUROSTIMULATORS PROGRAMMERS
First on market country: Netherlands
Safety summary (SSCP/SSP): 370034-002A_SSCP_BAROSTIM NEO_BAROSTIM LEGACY · Rev. Rev A v2.0
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:38

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

Barostim NEO2™ Generator

2104

Class IIIMDR 2017/745On the marketActive deviceImplantableSingle useSterile

Manufacturer: CVRx, Inc.
Manufacturer SRN: US-MF-000001082
UDI-DI: 00859144004425
Basic UDI-DI: 00859144004579JW
Reference: 100065-201
EMDN: J0209
EMDN description: CAROTID SINUS IMPLANTABLE NEUROSTIMULATORS AND LEADS
First on market country: Netherlands
Safety summary (SSCP/SSP): 370034-002A_SSCP_BAROSTIM NEO_BAROSTIM LEGACY · Rev. Rev A v2.0
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:38

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

Barostim™ Carotid Sinus Lead

1036

Class IIIMDR 2017/745On the marketActive deviceImplantableSingle useSterile

Manufacturer: CVRx, Inc.
Manufacturer SRN: US-MF-000001082
UDI-DI: 00859144004265
Basic UDI-DI: 00859144004555JG
Reference: 100063-211
EMDN: J0209
EMDN description: CAROTID SINUS IMPLANTABLE NEUROSTIMULATORS AND LEADS
First on market country: Netherlands
Safety summary (SSCP/SSP): 370034-002A_SSCP_BAROSTIM NEO_BAROSTIM LEGACY · Rev. Rev A v2.0
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:38

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

Barostim NEO™ Generator

2102

Class IIIMDR 2017/745On the marketActive deviceImplantableSingle useSterile

Manufacturer: CVRx, Inc.
Manufacturer SRN: US-MF-000001082
UDI-DI: 00859144004005
Basic UDI-DI: 00859144004524J5
Reference: 100054-201
EMDN: J0209
EMDN description: CAROTID SINUS IMPLANTABLE NEUROSTIMULATORS AND LEADS
First on market country: Netherlands
Safety summary (SSCP/SSP): 370034-002A_SSCP_BAROSTIM NEO_BAROSTIM LEGACY · Rev. Rev A v2.0
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:38

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

Atrostim PNS

AIMDD scopeAIMDDOn the marketActive deviceImplantableSingle useSterile

Manufacturer: Atrotech Oy
Manufacturer SRN: FI-MF-000015061
UDI-DI: D-2112095166
Basic UDI-DI: B-2112095166
Reference: na
EMDN: J0206
EMDN description: FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 15:27

Manufacturer products View details

Axonics Neurostimulator

1101

AIMDD scopeAIMDDOn the marketActive deviceImplantableSingle useSterile

Manufacturer: Axonics Inc.
Manufacturer SRN: US-MF-000008413
UDI-DI: 10810005340066
Basic UDI-DI: B-10810005340066
Reference: 1101
EMDN: J020402
EMDN description: INTESTINAL INCONTINENCE NEUROSTIMULATORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® Charger (AU)

5006

AIMDD scopeAIMDDOn the marketActive device

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000735
Basic UDI-DI: B-09352307000735
Reference: 5006
EMDN: J020280
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® Charger (UK)

4006

AIMDD scopeAIMDDOn the marketActive device

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000421
Basic UDI-DI: B-09352307000421
Reference: 4006
EMDN: J020280
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® Lead Adapter Kit

1028

AIMDD scopeAIMDDOn the marketSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000261
Basic UDI-DI: B-09352307000261
Reference: 1028
EMDN: J020280
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® External Closed Loop Stimulator (eCLS)

1020

AIMDD scopeAIMDDOn the marketActive device

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000216
Basic UDI-DI: B-09352307000216
Reference: 1020
EMDN: J020299
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - OTHER
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® 12C Trial Percutaneous Lead Kit - 90cm

1017

AIMDD scopeAIMDDOn the marketImplantableSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000209
Basic UDI-DI: B-09352307000209
Reference: 1017
EMDN: J020203
EMDN description: SPINAL NEUROSTIMULATION LEADS
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® 12C Trial Percutaneous Lead Kit - 60cm

1016

AIMDD scopeAIMDDOn the marketImplantableSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000186
Basic UDI-DI: B-09352307000186
Reference: 1016
EMDN: J020203
EMDN description: SPINAL NEUROSTIMULATION LEADS
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® Spares Kit

1015

AIMDD scopeAIMDDOn the marketImplantableSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000162
Basic UDI-DI: B-09352307000162
Reference: 1015
EMDN: J020280
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® Epidural Needle, 6.5”

1014

AIMDD scopeAIMDDOn the marketSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000148
Basic UDI-DI: B-09352307000148
Reference: 1014
EMDN: J020280
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® Tunnelling Tool

1012

AIMDD scopeAIMDDOn the marketSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000124
Basic UDI-DI: B-09352307000124
Reference: 1012
EMDN: J020280
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® 12C Lead Extension Kit - 55cm

1011

AIMDD scopeAIMDDOn the marketImplantableSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000117
Basic UDI-DI: B-09352307000117
Reference: 1011
EMDN: J020280
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® 12C Percutaneous Lead Kit - 90cm

1009

AIMDD scopeAIMDDOn the marketImplantableSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000094
Basic UDI-DI: B-09352307000094
Reference: 1009
EMDN: J020203
EMDN description: SPINAL NEUROSTIMULATION LEADS
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® 12C Percutaneous Lead Kit - 60cm

1008

AIMDD scopeAIMDDOn the marketImplantableSingle useSterile

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000070
Basic UDI-DI: B-09352307000070
Reference: 1008
EMDN: J020203
EMDN description: SPINAL NEUROSTIMULATION LEADS
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Evoke® Pocket Console (EPC)

1003

AIMDD scopeAIMDDOn the marketActive device

Manufacturer: Saluda Medical Pty Ltd
Manufacturer SRN: AU-MF-000010522
UDI-DI: 09352307000018
Basic UDI-DI: B-09352307000018
Reference: 1003
EMDN: J020280
EMDN description: SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 10.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details