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Neurosurgery

NEU 02

Class IIaMDR 2017/745On the marketSterile

Manufacturer: SYNDEO Medical
Manufacturer SRN: BE-PR-000044136
UDI-DI: 05065021834084
Basic UDI-DI: 5065021834SYNPP008ZF
Reference: SYN-NEU02-001
EMDN: Z12109099
EMDN description: VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 09:17

Manufacturer products View details

CUE1 for Parkinson's

CUE1

Class IMDR 2017/745No longer on the marketActive device

Manufacturer: CHARCO NEUROTECH LTD
Manufacturer SRN: GB-MF-000018851
UDI-DI: 05065010064003
Basic UDI-DI: 5065010064CUE1P4
Reference: CN000100
EMDN: Z12101106
EMDN description: NEUROLOGICAL STIMULATORS
First on market country: Spain
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 31.07.2026 09:15

Manufacturer products Authorised representative products Authorised representative actors View details

05060941990018

autoSCORE

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Holberg EEG AS
Manufacturer SRN: NO-MF-000019507
UDI-DI: 05060941990018
Basic UDI-DI: 506094199autoSCORESG
Reference: AS001 V2
EMDN: Z12100382
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Norway
Authorised representative: -
Last updated: 31.07.2026 08:57

Manufacturer products View details

Phagenyx

EPSB3

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Phagenesis Ltd
Manufacturer SRN: GB-MF-000015848
UDI-DI: 05060453480045
Basic UDI-DI: 506045348B039S
Reference: EPSB3
EMDN: Z12101106
EMDN description: NEUROLOGICAL STIMULATORS
First on market country: Germany
Authorised representative: Veranex Germany GmbH
Last updated: 31.07.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

05059358034453

Foot control pedals used in combination with surgical power tools to ream, bur, drill and cut bone

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zethon Ltd
Manufacturer SRN: GB-MF-000014309
UDI-DI: 05059358034453
Basic UDI-DI: 50605201INT02MAN07WE
Reference: FS-270
EMDN: Z12100980
EMDN description: INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: De Soutter Medical Limited
Last updated: 31.07.2026 08:41

Manufacturer products Authorised representative products Authorised representative actors View details

Trackit SOLO

Class IMDR 2017/745Not intended for EU marketActive device

Manufacturer: Lifelines Ltd.
Manufacturer SRN: GB-MF-000020001
UDI-DI: 05060275450790
Basic UDI-DI: 506027545SOLOBF
Reference: 1700UK
EMDN: Z12100380
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Incereb Ltd
Last updated: 31.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

Trackit T4 EEG Amplifier

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Lifelines Ltd.
Manufacturer SRN: GB-MF-000020001
UDI-DI: 05060275450479
Basic UDI-DI: 506027545T4P7
Reference: 1502
EMDN: Z12100302
EMDN description: ELECTROENCEPHALOGRAPHS
First on market country: Denmark
Authorised representative: Incereb Ltd
Last updated: 31.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

ELECTRO DETACH GENERATOR v4

Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: KANEKA Corporation
Manufacturer SRN: JP-MF-000022143
UDI-DI: 04540778186330
Basic UDI-DI: 4993478KNK0053Y
Reference: 347-404R
EMDN: Z12109001
EMDN description: DETACHABLE COIL EQUIPMENT FOR BRAIN ANEURYSMS
First on market country: Germany
Authorised representative: Kaneka Medical Europe N.V.
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

EEG Amplifier Unit JE-940A

Electroencephalograph

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921023143
Basic UDI-DI: 4931921MD2a0014LQ
Reference: JE-940AK
EMDN: Z12100302
EMDN description: ELECTROENCEPHALOGRAPHS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

MINI ELECTRODE JUNCTION BOX JE-944A

Electroencephalograph

Class IMDR 2017/745On the market

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921023044
Basic UDI-DI: 4931921MD10014BG
Reference: JE-944A
EMDN: Z12100380
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Breakout Box　JB-910B

Evoked-potential graphic recording system

Class IMDR 2017/745On the marketActive device

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921005477
Basic UDI-DI: 4931921MD10013BE
Reference: JB-910B
EMDN: Z12101180
EMDN description: PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Stress Electroencephalography Assessment System

SEA-0001

Class IIaMDR 2017/745On the market

Manufacturer: HippoScreen Neurotech Corp
Manufacturer SRN: TW-MF-000040551
UDI-DI: 04719897969029
Basic UDI-DI: 471989796SEA0001VC
Reference: SEA-0001
EMDN: Z12100392
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Luana Med. B.V.
Last updated: 31.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

8-CH Electroencephalography Amplifier

EAmp-0001

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: HippoScreen Neurotech Corp
Manufacturer SRN: TW-MF-000040551
UDI-DI: 04719897969012
Basic UDI-DI: 471989796EAmp0001US
Reference: EAmp-0001
EMDN: Z12100302
EMDN description: ELECTROENCEPHALOGRAPHS
First on market country: Netherlands
Authorised representative: Luana Med. B.V.
Last updated: 31.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Depth of Anaesthesia and Sedation Monitor MGA-06

Class IIbMDR 2017/745Not intended for EU marketActive device

Manufacturer: Triton Electronic Systems Ltd
Manufacturer SRN: RU-MF-000015915
UDI-DI: 04640102900622
Basic UDI-DI: 464010290MON001WN
Reference: MGA-06
EMDN: Z12100302
EMDN description: ELECTROENCEPHALOGRAPHS
First on market country: -
Authorised representative: Wladimir Wollert
Last updated: 31.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

orthoTRODE2

Bipolare Surface EMG electrode 21mm

Class IMDR 2017/745On the marketReprocessedSingle use

Manufacturer: SinfoMed Gesellschaft für Präventions-, Diagnose- und Rehasysteme mbH
Manufacturer SRN: DE-MF-000048702
UDI-DI: 04262516750008
Basic UDI-DI: 426251675EL016R
Reference: 121
EMDN: Z12100485
EMDN description: ELECTROMYOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:41

Manufacturer products View details

myoact EMG Biofeedbacktraining

myoact app

Class IMDR 2017/745On the marketDirect marking

Manufacturer: MYOact GmbH
Manufacturer SRN: DE-MF-000044341
UDI-DI: 04262494510007
Basic UDI-DI: 426249451myoactMK
Reference: 6.3.0
EMDN: Z12100492
EMDN description: ELECTROMYOGRAPHY INSTRUMENTS -MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:41

Manufacturer products View details

04262405062052

Esumedics Flash Goggles

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DeMeTec GmbH
Manufacturer SRN: DE-MF-000005062
UDI-DI: 04262405062052
Basic UDI-DI: 42624050620565
Reference: FG-419
EMDN: Z12100480
EMDN description: ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:31

Manufacturer products View details

Stimware EMG AutoMT

Stimware

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MAG & More GmbH
Manufacturer SRN: DE-MF-000012125
UDI-DI: 04260526056035
Basic UDI-DI: 426052605STIM150EH
Reference: 150621
EMDN: Z12101105
EMDN description: MAGNETIC STIMULATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:27

Manufacturer products View details

PMD70-pCool Sham

Stimulation Coils

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MAG & More GmbH
Manufacturer SRN: DE-MF-000012125
UDI-DI: 04260526055205
Basic UDI-DI: 426052605COIL5103Z
Reference: 510551
EMDN: Z12101105
EMDN description: MAGNETIC STIMULATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:27

Manufacturer products View details

PowerMAG Clinical 100 (220 V)

PowerMAG

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MAG & More GmbH
Manufacturer SRN: DE-MF-000012125
UDI-DI: 04260526051023
Basic UDI-DI: 426052605PMAG1125R
Reference: 112259
EMDN: Z12101105
EMDN description: MAGNETIC STIMULATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:27

Manufacturer products View details