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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

08720892067814

PCaVision

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Angiogenesis Analytics B.V.
Manufacturer SRN: NL-MF-000033108
UDI-DI: 08720892067814
Basic UDI-DI: 0872089PCaVisionSW48
Reference: PCaVision
EMDN: Z11049092
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:04

Manufacturer products View details

PCaVision Probe Fixture

Class IMDR 2017/745On the marketDirect markingReprocessed

Manufacturer: Angiogenesis Analytics B.V.
Manufacturer SRN: NL-MF-000033108
UDI-DI: 08720892067807
Basic UDI-DI: 0872089PCaVisionFIXJ4
Reference: PCaVision Probe Fixture
EMDN: Z11049080
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 07:04

Manufacturer products 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

Aquaflex Ultrasound Gel Pad

04-02

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parker Laboratories, Inc.
Manufacturer SRN: US-MF-000013857
UDI-DI: 10855683006828
Basic UDI-DI: 085568300604000H8
Reference: 04-15
EMDN: Z11049085
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Parker Laboratories, BV
Last updated: 16.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse Probe Cover

38-01

Class IMDR 2017/745On the marketSingle use

Manufacturer: Parker Laboratories, Inc.
Manufacturer SRN: US-MF-000013857
UDI-DI: 10855683006347
Basic UDI-DI: 085568300638000K5
Reference: 38-01
EMDN: Z11049085
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Parker Laboratories, BV
Last updated: 16.07.2026 06:46

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Polysonic Ultrasound Lotion

21-08

Class IMDR 2017/745On the marketAnimal tissues

Manufacturer: Parker Laboratories, Inc.
Manufacturer SRN: US-MF-000013857
UDI-DI: 10855683006286
Basic UDI-DI: 085568300620021HA
Reference: 20-08
EMDN: Z11049085
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Parker Laboratories, BV
Last updated: 16.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Aquasonic 100 Ultrasound Transmission Gel

01-08

Class IMDR 2017/745On the market

Manufacturer: Parker Laboratories, Inc.
Manufacturer SRN: US-MF-000013857
UDI-DI: 10855683006033
Basic UDI-DI: 085568300601003GR
Reference: 01-02
EMDN: Z11049085
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Parker Laboratories, BV
Last updated: 16.07.2026 06:46

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HYDROS TRUS Probe

HU1000

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: PROCEPT BioRobotics Corporation
Manufacturer SRN: US-MF-000015560
UDI-DI: 00850055427075
Basic UDI-DI: 0850055427HU1000NX
Reference: HU1000
EMDN: Z1104020201
EMDN description: ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

Sound Pro Combination Ultrasound Table 230V

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070620
Basic UDI-DI: 085994200610858
Reference: 058-715
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: -
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Ultra Pro Ultrasound Table

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070637
Basic UDI-DI: 085994200610858
Reference: 058-720
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: -
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Ultra Pro Ultrasound Table 230V

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070644
Basic UDI-DI: 085994200610858
Reference: 058-725
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: -
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Echo Pro Echocardiography Table

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070651
Basic UDI-DI: 085994200610858
Reference: 058-700
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: -
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Echo Pro Echocardiography Table 230V

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070668
Basic UDI-DI: 085994200610858
Reference: 058-705
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: -
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Econo Ultrasound Table

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070675
Basic UDI-DI: 085994200610858
Reference: 058-726
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: -
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Econo Ultrasound Table 230V

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070682
Basic UDI-DI: 085994200610858
Reference: 058-727
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: -
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

Econo Echocardiography Table

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mirion Technologies (Capintec), Inc.
Manufacturer SRN: US-MF-000000770
UDI-DI: 00879942070699
Basic UDI-DI: 085994200610858
Reference: 058-701
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: -
Authorised representative: Atlantico Systems, Ltd.
Last updated: 16.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details