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04560141940079

ULTRASOUND SYSTEM SONIMAGE HS2

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Konica Minolta, Inc.
Manufacturer SRN: JP-MF-000008214
UDI-DI: 04560141940079
Basic UDI-DI: 45601419200013189
Reference: A7AX
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: Germany
Authorised representative: Konica Minolta Business Solutions Europe GmbH
Last updated: 16.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Ultrasonic Processor SU-1 System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410578737
Basic UDI-DI: 454741020100000000001835Q
Reference: 04547410578737
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

Ultrasonic Processor SU-1

Ultrasonic Processor 2

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410335088
Basic UDI-DI: 454741020100000000001195F
Reference: 04547410335088
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

LifeDop™

L150R-SD4

Class IIaMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937001891
Basic UDI-DI: 0888937TD083ns43
Reference: L150R-SD4
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: Netherlands
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 16.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Ultrasound System 5500CV

5000 Compact Series Ultrasound Systems

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838116566
Basic UDI-DI: 0884838BM945TV
Reference: 795141
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

Extended Compact Cart, English

Ultrasound System Carts

Class IMDR 2017/745On the marketActive device

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838111653
Basic UDI-DI: 0884838BM789U7
Reference: 989606734941
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Lumify Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838100121
Basic UDI-DI: 0884838BM433SV
Reference: 795005
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

EPIQ 7 Diagnostic Ultrasound System

EPIQ Series Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838097841
Basic UDI-DI: 0884838BM431SR
Reference: 795117
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

Affiniti 50 Diagnostic Ultrasound System

Affiniti Series Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838097728
Basic UDI-DI: 0884838BM432ST
Reference: 795118
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

Lumify rugged cable

Cable and Cable Accessories

Class IMDR 2017/745On the marketActive device

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838094444
Basic UDI-DI: 0884838BM754TL
Reference: 453561943062
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

Flash Ultrasound System 5100 POC Pro

Flash Ultrasound System 5100 POC

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838115354
Basic UDI-DI: 0884838BM1163M6
Reference: 795158
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:12

Manufacturer products Authorised representative products Authorised representative actors View details

UroNav

UroNav 4

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips DS North America LLC
Manufacturer SRN: US-MF-000035802
UDI-DI: 00884838107069
Basic UDI-DI: 0884838BM419T3
Reference: 784039
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

X-CUBE i8

X-CUBE i

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Alpinion Medical Systems Co.,Ltd.
Manufacturer SRN: KR-MF-000012961
UDI-DI: 08800013542007
Basic UDI-DI: 0880001357200RB
Reference: X-CUBE i8
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Alpinion Medical Deutschland GmbH
Last updated: 16.07.2026 07:05

Manufacturer products Authorised representative products Authorised representative actors View details

X-CUBE 70

X-CUBE

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Alpinion Medical Systems Co.,Ltd.
Manufacturer SRN: KR-MF-000012961
UDI-DI: 08800013540003
Basic UDI-DI: 0880001357000QZ
Reference: X-CUBE 70
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Poland
Authorised representative: Alpinion Medical Deutschland GmbH
Last updated: 16.07.2026 07:05

Manufacturer products Authorised representative products Authorised representative actors View details

Minisono L3-12

Minisono

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Alpinion Medical Systems Co.,Ltd.
Manufacturer SRN: KR-MF-000012961
UDI-DI: 08800013530004
Basic UDI-DI: 0880001357400RM
Reference: Minisono L3-12
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Alpinion Medical Deutschland GmbH
Last updated: 16.07.2026 07:05

Manufacturer products Authorised representative products Authorised representative actors View details

E-CUBE i7

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Alpinion Medical Systems Co.,Ltd.
Manufacturer SRN: KR-MF-000012961
UDI-DI: 08800013526007
Basic UDI-DI: 0880001357300RG
Reference: E-CUBE i7
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Alpinion Medical Deutschland GmbH
Last updated: 16.07.2026 07:05

Manufacturer products Authorised representative products Authorised representative actors View details

E-CUBE 5

E-CUBE

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Alpinion Medical Systems Co.,Ltd.
Manufacturer SRN: KR-MF-000012961
UDI-DI: 08800013520005
Basic UDI-DI: 0880001357100R6
Reference: E-CUBE 5
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Alpinion Medical Deutschland GmbH
Last updated: 16.07.2026 07:05

Manufacturer products Authorised representative products Authorised representative actors View details

Sound Pro Combination Ultrasound Table

Ultrasound Tables

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070613
Basic UDI-DI: 085994200610858
Reference: 058-710
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: Northern Ireland
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

00860003586341

Caption AI on vScan

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Caption Health, Inc.
Manufacturer SRN: US-MF-000022891
UDI-DI: 00860003586341
Basic UDI-DI: 08600035863VSCAISM
Reference: 511-00022
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Caption Guidance

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Caption Health, Inc.
Manufacturer SRN: US-MF-000022891
UDI-DI: 00860003586334
Basic UDI-DI: 08600035863CAIMY
Reference: 511-00021
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details