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EpiMonitor by Empatica

EpiMonitor by Empatica iOS Version

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Empatica S.r.L.
Manufacturer SRN: IT-MF-000012905
UDI-DI: 00853858006379
Basic UDI-DI: 0853858006EpiAppX4
Reference: EpiMonitor-IOS
EMDN: Z121002
EMDN description: NERVOUS SYSTEM MONITORING SYSTEMS
First on market country: Ireland
Authorised representative: -
Last updated: 16.07.2026 06:39

Manufacturer products View details

PoSAS

Positional Sleep Assessment System (PoSAS) Software

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Advanced Brain Monitoring, Inc.
Manufacturer SRN: US-MF-000011252
UDI-DI: 00851113007758
Basic UDI-DI: 0851113007PS34PZ
Reference: PS34-5401
EMDN: Z12100592
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: MPS Medical Product Service GmbH
Last updated: 16.07.2026 06:33

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

00850298007218

Monitoring Cable, Gray System IV

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007218
Basic UDI-DI: 08502980072197
Reference: ECEF-4
EMDN: Z12100385
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

ECT Treatment Cable

ECT Treatment Cable/Bk

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007201
Basic UDI-DI: 08502980072095
Reference: ECET-P
EMDN: Z12109002
EMDN description: ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

00850298007188

Insulated Handle

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007188
Basic UDI-DI: 0850298007189J
Reference: EHAN
EMDN: Z12100380
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

00850298007164

Remote Treatment Handle

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007164
Basic UDI-DI: 0850298007169E
Reference: ERTH
EMDN: Z12109002
EMDN description: ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

00850298007157

Steel Electrode, Cupped

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007157
Basic UDI-DI: 0850298007159C
Reference: EECU
EMDN: Z12100380
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

00850298007058

Mouth Protector (EMGS)

Class IMDR 2017/745On the market

Manufacturer: Somatics, LLC
Manufacturer SRN: US-MF-000011550
UDI-DI: 00850298007058
Basic UDI-DI: 08502980070599
Reference: EMGS
EMDN: Z12100385
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: FBI Medizintechnik GmbH
Last updated: 16.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details