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RTmedes 1.6

RTmedes

Class IMDR 2017/745On the marketActive device

Manufacturer: TatraMed Software s.r.o.
Manufacturer SRN: SK-MF-000017681
UDI-DI: 08588008910016
Basic UDI-DI: 8588008910-RTmedes-PA
Reference: RTmedes - Build: 1.6.21168.1
EMDN: Z119092
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Slovakia
Authorised representative: -
Last updated: 31.07.2026 23:11

Manufacturer products View details

SPY-PHI Articulating Arm, Table Clamp

AA-0100

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Axcess Surgical Innovations LLC.
Manufacturer SRN: US-MF-000014666
UDI-DI: 00810007560014
Basic UDI-DI: 81000756AXS00016J
Reference: HH1002
EMDN: Z119099
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Axcess Surgical Innovations B.V.
Last updated: 31.07.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

SPY-PHI Articulating Arm, Main Arm

AA-0100

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Axcess Surgical Innovations LLC.
Manufacturer SRN: US-MF-000014666
UDI-DI: 00810007560007
Basic UDI-DI: 81000756AXS00016J
Reference: HH1001
EMDN: Z119099
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Axcess Surgical Innovations B.V.
Last updated: 31.07.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

Sentinel 4DCT

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: C-RAD Positioning AB
Manufacturer SRN: SE-MF-000022326
UDI-DI: 07350005280017
Basic UDI-DI: 735000528SentinelG9
Reference: SP001-0022
EMDN: Z119010
EMDN description: LASER SYSTEMS FOR PATIENT POSITIONING
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:01

Manufacturer products View details

L-Type Neck-Thorax Mask Large T-2.4mm

Thermoplastic Masks

Class IMDR 2017/745On the marketSingle use

Manufacturer: Guangdong Meicen Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000039245
UDI-DI: 06977071934715
Basic UDI-DI: 697707193001MB
Reference: M2422-VLF197W
EMDN: Z119099
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 31.07.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

06920824126523

Many

Class IMDR 2017/745On the market

Manufacturer: Klarity Medical & Equipment（GZ） Co.,Ltd.
Manufacturer SRN: CN-MF-000002229
UDI-DI: 06920824126523
Basic UDI-DI: 692082412652DK
Reference: K-ARL-M3
EMDN: Z119010
EMDN description: LASER SYSTEMS FOR PATIENT POSITIONING
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Thermidas VistaClinic Analyzer

Version 1.5

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: TherMidas Oy
Manufacturer SRN: FI-MF-000007644
UDI-DI: 06429810718044
Basic UDI-DI: 6429810718VistaAnalyzerD6
Reference: ThAnalzyer
EMDN: Z119092
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:44

Manufacturer products View details

Thermidas IRT-384 Tablet

ThIR-384

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: TherMidas Oy
Manufacturer SRN: FI-MF-000007644
UDI-DI: 06429810718037
Basic UDI-DI: 6429810718IRT384TabletNY
Reference: ThIRT-384
EMDN: Z119013
EMDN description: THERMOGRAPHS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:44

Manufacturer products View details

RADU v.16.0

Radu RIS

Class IMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: L-Force Oy
Manufacturer SRN: FI-MF-000006911
UDI-DI: 06429810604002
Basic UDI-DI: 6429810604RADU76
Reference: 06429810604002
EMDN: Z119082
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

Manufacturer products View details

SkinSensic głowica dermatoskopowa do nieinwazyjnego obrazowania zmian skórnych alergicznych

SS024-IRVIS

Class IMDR 2017/745On the marketActive device

Manufacturer: MILTON ESSEX SA
Manufacturer SRN: PL-MF-000019079
UDI-DI: 05904473299655
Basic UDI-DI: 5904473299SKINSENSIC24C9
Reference: SS045-IRVIS
EMDN: Z119013
EMDN description: THERMOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:42

Manufacturer products View details

Apollo Smart Protocol

Apollo Brain

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Cerebriu A/S
Manufacturer SRN: DK-MF-000036703
UDI-DI: 05745000912018
Basic UDI-DI: 5745000912ABSMRIV1.0TG
Reference: 2-4103-3
EMDN: Z119092
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 12:41

Manufacturer products View details

Barco

Surgical display

Class IMDR 2017/745On the marketActive device

Manufacturer: Barco (Suzhou) Healthcare Technology Co., Ltd.
Manufacturer SRN: CN-MF-000017575
UDI-DI: 05415334030732
Basic UDI-DI: 5415334_Console_CG
Reference: K9350467
EMDN: Z11900802
EMDN description: BIOIMAGING VIEWING MONITORS
First on market country: Belgium
Authorised representative: Barco NV
Last updated: 31.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

Barco

Pathology Display

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334033665
Basic UDI-DI: 5415334_Pathology_X4
Reference: K9301101A
EMDN: Z11900801
EMDN description: BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:01

Manufacturer products View details

Coronis

Radiology Display

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334002340
Basic UDI-DI: 5415334_Radiology_PX
Reference: K9301626A
EMDN: Z11900801
EMDN description: BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:00

Manufacturer products View details

Barco

surgical monitor

Class IMDR 2017/745On the marketActive device

Manufacturer: BARCO S.R.L.
Manufacturer SRN: IT-MF-000026408
UDI-DI: 05415334002302
Basic UDI-DI: 5415334_Surgical-IT_BT
Reference: K9352053
EMDN: Z11900802
EMDN description: BIOIMAGING VIEWING MONITORS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:00

Manufacturer products View details

Barco

Surgical Display

Class IMDR 2017/745On the marketActive device

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334001176
Basic UDI-DI: 5415334_Surgical-BE_9B
Reference: 991932209081
EMDN: Z11900802
EMDN description: BIOIMAGING VIEWING MONITORS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:00

Manufacturer products View details

Eonis

Clinical Review Display

Class IMDR 2017/745On the marketActive device

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334001152
Basic UDI-DI: 5415334_Clinical-BE_AV
Reference: K9301820A
EMDN: Z11900802
EMDN description: BIOIMAGING VIEWING MONITORS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:00

Manufacturer products View details

Nio

Radiology Display

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334001138
Basic UDI-DI: 5415334_Tomo_KW
Reference: K9300361A
EMDN: Z11900801
EMDN description: BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:00

Manufacturer products View details

Barco

Clinical Review Display

Class IMDR 2017/745On the marketActive device

Manufacturer: BARCO S.R.L.
Manufacturer SRN: IT-MF-000026408
UDI-DI: 05415334000452
Basic UDI-DI: 5415334_Clinical-IT_DD
Reference: K9350055
EMDN: Z11900802
EMDN description: BIOIMAGING VIEWING MONITORS
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 11:00

Manufacturer products View details

Nio

Radiology Display

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334000384
Basic UDI-DI: 5415334_Dental_9N
Reference: K9300330A
EMDN: Z11900801
EMDN description: BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:00

Manufacturer products View details