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45 device results listed.

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IRRAflow Drainage Collection System

DCS 010

Class IMDR 2017/745On the marketMeasuring functionSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00868643000470
Basic UDI-DI: 086864300047CZ
Reference: DCS 010
EMDN: N01038099
EMDN description: INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 07:01

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame XG Targeting Cannula

NGS-TC-01

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007840
Basic UDI-DI: 0850376007848N
Reference: NGS-TC-01
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

MR Neuro Drape Tapered (Siemens/Philips)-Long

MR Drape

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007802
Basic UDI-DI: 0850376007808E
Reference: NGS-PD-02-L-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame Scalp Mount Base – Europe

NGS-SM-01-E

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007697
Basic UDI-DI: 0850376007698S
Reference: NGS-SM-01-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame XG – Europe

NGS-SF-02-11-5-E

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007680
Basic UDI-DI: 0850376007688Q
Reference: NGS-SF-02-11-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame XG Exchangeable Device Guide, 5.4-mm

NGS-XG-01-E

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007666
Basic UDI-DI: 0850376007798V
Reference: NGS-XG-06
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Inflexion Avanto HFF

ClearPoint Inflexion

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007482
Basic UDI-DI: 0850376007488J
Reference: CP-INHFF-112-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

ClearPoint Multi-Positional Upper Fixation Frame Screws

ClearPoint Multi-Positional HFF Screws

Class IMDR 2017/745On the market

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007376
Basic UDI-DI: 0850376007378D
Reference: CP-FFSMPU-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

ClearPoint Siemens Sola / Vida Multi-Positional HFF

ClearPoint Multi-Positional HFF

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007000
Basic UDI-DI: 08503760072484
Reference: CP-MPHFF-132-01
EMDN: Z12100680
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

SmartTwist MR Hand Drill

NGS-HD-01

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850359007348
Basic UDI-DI: 0850359007348C
Reference: NGS-HD-01
EMDN: Z12100902
EMDN description: DRILLS FOR NEUROSURGERY
First on market country: Denmark
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame Guide Tubes (Set)

NGS-GT-01

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850359007232
Basic UDI-DI: 08503590072387
Reference: NGS-GT-01
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

SmartFrame Thumb Wheel Extension Set

NGS-TE-01

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850359007171
Basic UDI-DI: 0850359007178C
Reference: NGS-TE-01
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

SmartGrid Planning Grid

NGS-SG-01-11

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850359007140
Basic UDI-DI: 08503590071486
Reference: NGS-SG-01-11
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

ClearPoint

CP-SFW-11-30

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850047354099
Basic UDI-DI: 0850047354096W
Reference: CP-SFW-11-30
EMDN: Z12100692
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

Depth Stop, 6 Pack

NGS-DS-06

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850047354082
Basic UDI-DI: 0850047354086U
Reference: NGS-DS-06
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

SMARTFrame Accessory Kit, 7 Fr - Europe

NGS-AK-01-11-7-E

Class IIIMDDOn the marketMeasuring functionSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007741
Basic UDI-DI: B-00850376007741
Reference: NGS-AK-01-11-7-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:09

Manufacturer products Authorised representative products Authorised representative actors View details

SMARTFrame Accessory Kit, 5 Fr - Europe

NGS-AK-01-11-5-E

Class IIIMDDOn the marketMeasuring functionSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850359007522
Basic UDI-DI: B-00850359007522
Reference: NGS-AK-01-11-5-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:09

Manufacturer products Authorised representative products Authorised representative actors View details

SMARTFrame Accessory Kit, 4 Fr - Europe

NGS-AK-01-11-4-E

Class IIIMDDOn the marketMeasuring functionSingle useSterile

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850359007515
Basic UDI-DI: B-00850359007515
Reference: NGS-AK-01-11-4-E
EMDN: Z12100685
EMDN description: STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:09

Manufacturer products Authorised representative products Authorised representative actors View details

ClearPoint SMS Avanto Table Multi-Positional HFF

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007246
Basic UDI-DI: 08503760072484
Reference: CP-MPHFF-112-01
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

ClearPoint Siemens Aera / Skyra Multi-Positional HFF

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ClearPoint Neuro, Inc.
Manufacturer SRN: US-MF-000010239
UDI-DI: 00850376007253
Basic UDI-DI: 08503760072484
Reference: CP-MPHFF-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