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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

10841716102643

Class INot specifiedOn the market

Manufacturer: ACIST Medical Systems, Inc.
Manufacturer SRN: US-MF-000010784
UDI-DI: 10841716102643
Basic UDI-DI: 08417161000009G5
Reference: 017991
EMDN: Z11049080
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: ACIST Europe BV
Last updated: 16.07.2026 08:16

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

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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

Onvision System

Class IMDR 2017/745No longer on the marketActive device

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838090668
Basic UDI-DI: 0884838BM659TR
Reference: 453561943492
EMDN: Z11049099
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 07:21

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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