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EUDAMED Device Search

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

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02.08.2026 22:01

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209 device results listed.

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ClearPoint Inflexion Aera-Skyra HFF

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007499
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-122-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion IMRIS Universal HFF

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007505
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-232-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion Siemens Sola-Vida HFF

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007512
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-132-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion GE HDw-450w HFF

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007536
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-322-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion GE 750w HFF

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007543
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-332-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion Philips Achieva HFF

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007550
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-412-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion Philips Ingenia HFF

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007567
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-422-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion GE Premier

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007574
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-342-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion IMRIS Aera-Skyra HFF

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Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007581
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-242-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame XG, 5 Fr – Europe

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Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007765
Basic UDI-DI: 0850376007688Q
Reference: NGS-SF-02-11-5-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame XG Exchangeable Device Guide, 2.5 mm – Europe

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Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007772
Basic UDI-DI: 0850376007798V
Reference: NGS-XG-03-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame XG Exchangeable Device Guide, 4.5 mm – Europe

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Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007789
Basic UDI-DI: 0850376007798V
Reference: NGS-XG-02-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame XG Exchangeable Device Guides – Europe

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Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007796
Basic UDI-DI: 0850376007798V
Reference: NGS-XG-01-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

MR Neuro Drape Tapered w/Extension (GE)-Long

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Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007819
Basic UDI-DI: 0850376007808E
Reference: NGS-PD-03-L-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

MR Bore Drape w/Extension (IMRIS)

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Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007826
Basic UDI-DI: 0850376007808E
Reference: NGS-PD-04-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

MR Patient Drape (IMRIS)

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Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007833
Basic UDI-DI: 0850376007808E
Reference: NGS-PD-05-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 25.06.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Leksell Vantage X-Ray Table Fixation

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Class IMDR 2017/745On the marketDirect marking

Manufacturer: Elekta Solutions AB
Manufacturer SRN: SE-MF-000002125
UDI-DI: 07340201503751
Basic UDI-DI: 073402015BUDI000000019PS
Reference: 1136512
EMDN: Z12100601
EMDN description: STEREOTACTIC NEUROSURGERY SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 24.06.2026 22:43

Manufacturer products View details

Leksell Vantage X-Ray Universal Fixation

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Class IMDR 2017/745On the marketDirect marking

Manufacturer: Elekta Solutions AB
Manufacturer SRN: SE-MF-000002125
UDI-DI: 07340201503775
Basic UDI-DI: 073402015BUDI000000019PS
Reference: 1136528
EMDN: Z12100601
EMDN description: STEREOTACTIC NEUROSURGERY SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 24.06.2026 22:43

Manufacturer products View details

RM-Schienenhalter für MSV an RM-Stereotaxiesystem,

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Class INot specifiedOn the marketDirect marking

Manufacturer: inomed Medizintechnik GmbH
Manufacturer SRN: DE-MF-000005589
UDI-DI: 04250307605019
Basic UDI-DI: 42503076FZS100AN
Reference: 590041
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 23.06.2026 11:03

Manufacturer products View details

Micromar-Adapter für MSV an Micromar-Stereotaxiesystem

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Class INot specifiedOn the marketDirect marking

Manufacturer: inomed Medizintechnik GmbH
Manufacturer SRN: DE-MF-000005589
UDI-DI: 04250307605033
Basic UDI-DI: 42503076FZS100AN
Reference: 590049
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 23.06.2026 11:03

Manufacturer products View details