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Brainomix 360 e-CTA

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Brainomix Limited
Manufacturer SRN: GB-MF-000017336
UDI-DI: *+B720ECTA120CE0
Basic UDI-DI: ++B720ECTACEQR
Reference: e-CTA 12.0
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

Brainomix 360 e-ASPECTS

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Brainomix Limited
Manufacturer SRN: GB-MF-000017336
UDI-DI: *+B720EASPECTS120CE0
Basic UDI-DI: ++B720EASPECTSCEGK
Reference: e-ASPECTS 12.0
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

TeraRecon Neuro

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TeraRecon, Inc.
Manufacturer SRN: US-MF-000008772
UDI-DI: +B220NEURO020
Basic UDI-DI: ++B220NeuroFP
Reference: 2
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Intuition

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TeraRecon, Inc.
Manufacturer SRN: US-MF-000008772
UDI-DI: +B220INTUITION040
Basic UDI-DI: ++B220INTUITIONFV
Reference: 4
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

TeraRecon Cardiovascular.Calcification.CT

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TeraRecon, Inc.
Manufacturer SRN: US-MF-000008772
UDI-DI: +B220CARDIOVASCCALCT10
Basic UDI-DI: ++B220CALCIFICATIONCTLV
Reference: 1
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

TeraRecon Cardiac.Chambers.MR

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TeraRecon, Inc.
Manufacturer SRN: US-MF-000008772
UDI-DI: +B220CARDIACCHAMBERSMR10
Basic UDI-DI: ++B220CHAMBERSMRZS
Reference: 1
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

TeraRecon Aorta.CT

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TeraRecon, Inc.
Manufacturer SRN: US-MF-000008772
UDI-DI: +B220AORTACT0
Basic UDI-DI: ++B220AORTACTQP
Reference: 1
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

TLX

Class IIbMDDOn the marketActive device

Manufacturer: Technix S.p.A.
Manufacturer SRN: IT-MF-000007797
UDI-DI: D-TLXGJ
Basic UDI-DI: B-TLXGJ
Reference: TLX
EMDN: Z11030503
EMDN description: PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 10:58

Manufacturer products View details

TeraRecon Neuro

Class IIaMDDOn the marketActive device

Manufacturer: TeraRecon, Inc.
Manufacturer SRN: US-MF-000008772
UDI-DI: NEURO02
Basic UDI-DI: B-NEURO02
Reference: Neuro
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 05:31

Manufacturer products Authorised representative products Authorised representative actors View details

Intuition

Class IIaMDDOn the marketActive device

Manufacturer: TeraRecon, Inc.
Manufacturer SRN: US-MF-000008772
UDI-DI: INTUITION04
Basic UDI-DI: B-INTUITION04
Reference: Intuition
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

B359OAIIV11

OmegaAI Image Viewer

Class IMDDOn the market

Manufacturer: RamSoft Inc.
Manufacturer SRN: CA-MF-000038450
UDI-DI: B359OAIIV11
Basic UDI-DI: B-B359OAIIV11
Reference: OAIIV1
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: AF Pharma Service Europe SL
Last updated: 12.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

Medis Suite MRCT

2025

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Medis Medical Imaging Systems bv
Manufacturer SRN: NL-MF-000002670
UDI-DI: B141MEDISSUITEMRCT2025
Basic UDI-DI: B-B141MEDISSUITEMRCT2025
Reference: 20250203
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 21:42

Manufacturer products View details

OsiriX MD

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Pixmeo SARL
Manufacturer SRN: CH-MF-000037624
UDI-DI: D-7649990819013GP
Basic UDI-DI: B-7649990819013GP
Reference: OsiriX MD
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Opale
Last updated: 12.07.2026 09:13

Manufacturer products Authorised representative products Authorised representative actors View details

contextflow SEARCH Lung CT