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SonoSite Edge II

SONOSITE EDGE II ULTRASOUND SYSTEM

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Fujifilm Sonosite, Inc.
Manufacturer SRN: US-MF-000001075
UDI-DI: 00841517105501
Basic UDI-DI: 08415171EDGEII8S
Reference: P20680-18
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: Italy
Authorised representative: Fujifilm Sonosite B.V.
Last updated: 16.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

AC/DC Power Adapter

AC POWER SUPPLY

Class IMDR 2017/745On the market

Manufacturer: Fujifilm Sonosite, Inc.
Manufacturer SRN: US-MF-000001075
UDI-DI: 00841517105198
Basic UDI-DI: 08415171LWNSPWRSPLYPA
Reference: P09823-20
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: Italy
Authorised representative: Fujifilm Sonosite B.V.
Last updated: 16.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

SonoSite SII

SONOSITE SII ULTRASOUND SYSTEM

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Fujifilm Sonosite, Inc.
Manufacturer SRN: US-MF-000001075
UDI-DI: 00841517103682
Basic UDI-DI: 08415171SIIUP
Reference: P23630-14R
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: -
Authorised representative: Fujifilm Sonosite B.V.
Last updated: 16.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

SonoSite Stand

SONOSITE STAND

Class IMDR 2017/745On the market

Manufacturer: Fujifilm Sonosite, Inc.
Manufacturer SRN: US-MF-000001075
UDI-DI: 00841517102159
Basic UDI-DI: 08415171STNDMX
Reference: P21432-06
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: Austria
Authorised representative: Fujifilm Sonosite B.V.
Last updated: 16.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

SonoSite M-Turbo

M-TURBO ULTRASOUND SYSTEM

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Fujifilm Sonosite, Inc.
Manufacturer SRN: US-MF-000001075
UDI-DI: 00841517101282
Basic UDI-DI: 08415171MTURBONC
Reference: P08189-88
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: -
Authorised representative: Fujifilm Sonosite B.V.
Last updated: 16.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

Triple Transducer Connect

TRIPLE TRANSDUCER CONNECT

Class IMDR 2017/745On the market

Manufacturer: Fujifilm Sonosite, Inc.
Manufacturer SRN: US-MF-000001075
UDI-DI: 00841517100131
Basic UDI-DI: 08415171TTCMDLLG
Reference: P16535-51
EMDN: Z1104018099
EMDN description: ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER
First on market country: Austria
Authorised representative: Fujifilm Sonosite B.V.
Last updated: 16.07.2026 05:11

Manufacturer products Authorised representative products Authorised representative actors View details

4D View 18

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: GE Healthcare Austria GmbH & Co OG
Manufacturer SRN: AT-MF-000001461
UDI-DI: 00840682137621
Basic UDI-DI: 08406821BUG004647E
Reference: 5789738
EMDN: Z11040192
EMDN description: ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 05:02

Manufacturer products View details

Lung Guidance

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00198953160084
Basic UDI-DI: 08406821BUG006437G
Reference: 5984278
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:58

Manufacturer products Authorised representative products Authorised representative actors View details

AutoAs

Automated Aortic Stenosis Software (AutoAS)

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00198953100509
Basic UDI-DI: 08406821BUG006427E
Reference: 9685077
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

00198953043455

LOGIQ Focus X R1, LOGIQ Focus S R1,

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00198953043455
Basic UDI-DI: 08406821BUG006327B
Reference: 5984527
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

Vivid Advanced

Vivid Explorer, Vivid Advanced, Vivid Focus

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Vingmed Ultrasound AS
Manufacturer SRN: NO-MF-000000553
UDI-DI: 00198953040256
Basic UDI-DI: 08406821BUG0061173
Reference: Vivid Advanced v211 / TC001008
EMDN: Z11040102
EMDN description: CARDIOLOGY ULTRASOUND SCANNERS
First on market country: Norway
Authorised representative: -
Last updated: 16.07.2026 04:57

Manufacturer products View details

Caption Interpretation

5700636

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00198953038284
Basic UDI-DI: 08406821BUG005487M
Reference: 5700636
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

Caption AI

5700645

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00198953030233
Basic UDI-DI: 08406821BUG005477K
Reference: 5984922
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

ACUSON Origin Diagnostic Ultrasound System

MDR_07_IIA_IQH_BTS LB A_ACDV_Origin_11668590_11669400

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Siemens Medical Solutions USA Inc.
Manufacturer SRN: US-MF-000012284
UDI-DI: 04056869996295
Basic UDI-DI: 0405686902471VU
Reference: 11668590
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Siemens Healthcare s.r.o.
Last updated: 16.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

ACUSON Sequoia Diagnostic Ultrasound System

MDR_07_IIA_IQH_BTS LB A_ACDV_Sequoia_11148775_11658635

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Siemens Medical Solutions USA Inc.
Manufacturer SRN: US-MF-000012284
UDI-DI: 04056869173566
Basic UDI-DI: 0405686902468W7
Reference: 11148775
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Siemens Healthcare s.r.o.
Last updated: 16.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Butterfly iQ+ Ultrasound System

850-20014

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Butterfly Network, Inc.
Manufacturer SRN: US-MF-000008565
UDI-DI: 00866646000213
Basic UDI-DI: 00866646000213KJ
Reference: 850-20014
EMDN: Z11040106
EMDN description: HANDHELD ULTRASOUND SCANNERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Butterfly iQ+ Bladder Ultrasound System

850-20028-XX

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect markingMeasuring function

Manufacturer: Butterfly Network, Inc.
Manufacturer SRN: US-MF-000008565
UDI-DI: 00850027593081
Basic UDI-DI: 00850027593081E6
Reference: 850-20028-XX
EMDN: Z11040106
EMDN description: HANDHELD ULTRASOUND SCANNERS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Butterfly iQ3 Ultrasound System

850-20026-XX

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Butterfly Network, Inc.
Manufacturer SRN: US-MF-000008565
UDI-DI: 00850027593029
Basic UDI-DI: 00850027593029E4
Reference: 850-20026-XX
EMDN: Z11040106
EMDN description: HANDHELD ULTRASOUND SCANNERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Medisono

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Medisono LCC
Manufacturer SRN: US-MF-000004807
UDI-DI: B369MUS01002
Basic UDI-DI: ++B369MUS0EN
Reference: MUS01002
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

Summit Doppler™ LifeDop®

Class IIaMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937001907
Basic UDI-DI: 0888937TD083ns43
Reference: L150R-SD5
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details