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Transducer L15-7io

Surgically Invasive Transducers

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838061491
Basic UDI-DI: 0884838BM429T6
Reference: 989605387852
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

Transducer C9-4v, Variant 1

Invasive (Rectal/Vaginal) Transducers

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838061392
Basic UDI-DI: 0884838BM430SP
Reference: 989605389252
EMDN: Z1104020201
EMDN description: ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:19

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Transducer D2cwc

Non-Invasive Transducers

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838061347
Basic UDI-DI: 0884838BM428T4
Reference: 989605412052
EMDN: Z11040299
EMDN description: ULTRASOUND PROBES – OTHER
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:19

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Transducer X7-2t

Invasive (Transesophageal) Transducers

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838023987
Basic UDI-DI: 0884838BM427T2
Reference: 989605361911
EMDN: Z1104020302
EMDN description: TRANSESOPHAGEAL ULTRASOUND PROBES, MULTIDIMENSIONAL
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:19

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Ultrasound Workspace

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838125186
Basic UDI-DI: 0884838BM1735MX
Reference: 300013759461
EMDN: Z11049092
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:13

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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

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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

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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

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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

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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

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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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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