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08908023670014

DeepTek CXR AI

Class IIbMDR 2017/745On the marketActive device

Manufacturer: DeepTek Medical Imaging Private Limited
Manufacturer SRN: IN-MF-000040297
UDI-DI: 08908023670014
Basic UDI-DI: 8908023670DT0032K
Reference: DeepTek_003
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Specculo Limited
Last updated: 03.07.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

08908023670007

Augmento

Class IMDR 2017/745On the marketActive device

Manufacturer: DeepTek Medical Imaging Private Limited
Manufacturer SRN: IN-MF-000040297
UDI-DI: 08908023670007
Basic UDI-DI: 8908023670DT0012F
Reference: DeepTek_001
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Malta
Authorised representative: Specculo Limited
Last updated: 03.07.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

RADSpa

RADSpa® Version 4.2.4

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: Telerad Tech Private Limited
Manufacturer SRN: IN-MF-000026224
UDI-DI: 08908008302008
Basic UDI-DI: 8908008302RADSpaH6
Reference: RADSpa®
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

FREEDOM i

DSI-100

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DOF Inc
Manufacturer SRN: KR-MF-000041580
UDI-DI: 08809972790009
Basic UDI-DI: 880997279DSI-100X2
Reference: DSI-100
EMDN: Z11069001
EMDN description: BIOIMAGING PROCESSORS
First on market country: Germany
Authorised representative: JaviTech e.K.
Last updated: 03.07.2026 21:06

Manufacturer products Authorised representative products Authorised representative actors View details

08809278790154

INFINITT DoseM

Class IMDR 2017/745On the marketActive device

Manufacturer: INFINITT Healthcare Co., Ltd.
Manufacturer SRN: KR-MF-000010998
UDI-DI: 08809278790154
Basic UDI-DI: 880927879DoseM85
Reference: 1307
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:50

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CONNEVO KOA

CONNEVO KOA V1.1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: CONNECTEVE Co., Ltd.
Manufacturer SRN: KR-MF-000043802
UDI-DI: 08800252360004
Basic UDI-DI: 880025236CONKCB
Reference: CONK01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Javitech Consulting GmbH
Last updated: 03.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Lunit INSIGHT CXR

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Lunit Inc.
Manufacturer SRN: KR-MF-000005200
UDI-DI: 08800076000094
Basic UDI-DI: 88000760CXRXN
Reference: 113012
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Lunit INSIGHT MMG

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Lunit Inc.
Manufacturer SRN: KR-MF-000005200
UDI-DI: 08800076000056
Basic UDI-DI: 88000760MMGXH
Reference: 124012
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

08800045800113

VN-M-02

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VUNO Inc.
Manufacturer SRN: KR-MF-000022266
UDI-DI: 08800045800113
Basic UDI-DI: 88000458VCXZ8
Reference: VN-M-02
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

08800045800106

VN-M-06

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VUNO Inc.
Manufacturer SRN: KR-MF-000022266
UDI-DI: 08800045800106
Basic UDI-DI: 88000458VDPYT
Reference: VN-M-06
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

08800045800083

VN-M-04

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VUNO Inc.
Manufacturer SRN: KR-MF-000022266
UDI-DI: 08800045800083
Basic UDI-DI: 88000458VLCYR
Reference: VN-M-04
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

08800045800007

VN-M-01

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VUNO Inc.
Manufacturer SRN: KR-MF-000022266
UDI-DI: 08800045800007
Basic UDI-DI: 88000458VBAXP
Reference: VN-M-01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

GEMPACS

Class IMDR 2017/745On the marketActive device

Manufacturer: DRGEM Corporation
Manufacturer SRN: KR-MF-000017990
UDI-DI: 08800011170028
Basic UDI-DI: 88000111RPSGEM6000P2
Reference: GEMPACS
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

08720892617644

Lumi Calculation Functions

Class IMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Augmedit B.V.
Manufacturer SRN: NL-MF-000045948
UDI-DI: 08720892617644
Basic UDI-DI: 87208926176LumiCFEM
Reference: 01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

Lumi Referenced

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Augmedit B.V.
Manufacturer SRN: NL-MF-000045948
UDI-DI: 08720892617620
Basic UDI-DI: 87208926176LumiRef8J
Reference: 01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

Lumi Segment

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Augmedit B.V.
Manufacturer SRN: NL-MF-000045948
UDI-DI: 08720892617613
Basic UDI-DI: 87208926176LumiSegmentN7
Reference: 01
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

Lumi Prepare

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Augmedit B.V.
Manufacturer SRN: NL-MF-000045948
UDI-DI: 08720892617606
Basic UDI-DI: 87208926176LumiPrepareQN
Reference: 01
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

VisiQuick

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Citodent Imaging B.V.
Manufacturer SRN: NL-MF-000000754
UDI-DI: 08720299734302
Basic UDI-DI: 872029973431001QQ
Reference: VisiQuick
EMDN: Z11060292
EMDN description: DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:49

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Untire

Class IMDR 2017/745On the marketActive device

Manufacturer: Tired of Cancer BV
Manufacturer SRN: NL-MF-000000800
UDI-DI: 08720299218024
Basic UDI-DI: 87202992180UntireFU
Reference: 08720299218024
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:47

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EVOCS

Class IMDR 2017/745On the marketActive device

Manufacturer: Fysicon B.V.
Manufacturer SRN: NL-MF-000002694
UDI-DI: 08720254542751
Basic UDI-DI: 8719689142EVOCSP8
Reference: 010147xxx
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:39

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