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Vscan Air CL

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Vingmed Ultrasound AS
Manufacturer SRN: NO-MF-000000553
UDI-DI: 00195278875860
Basic UDI-DI: 08406821BUG005097B
Reference: GP000160
EMDN: Z110402010201
EMDN description: CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY)
First on market country: Norway
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

00195278877116

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278877116
Basic UDI-DI: 8406821BUG00347HM
Reference: LOGIQ Totus R4 to R5 UPG / 5962804
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

00195278877123

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00195278877123
Basic UDI-DI: 8406821BUG00028H2
Reference: 5962802 / LOGIQ E10 R4 to R5 upgrade
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

00195278877130

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278877130
Basic UDI-DI: 8406821BUG00214GZ
Reference: LOGIQ Fortis R4 to R5 UPG / 5962803
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Vscan Air

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Vingmed Ultrasound AS
Manufacturer SRN: NO-MF-000000553
UDI-DI: 00195278884725
Basic UDI-DI: 8406821BUG00375HS
Reference: Vscan Air R3 for Android
EMDN: Z11040192
EMDN description: ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

Vscan Air

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Vingmed Ultrasound AS
Manufacturer SRN: NO-MF-000000553
UDI-DI: 00195278884749
Basic UDI-DI: 8406821BUG00375HS
Reference: Vscan Air R3 for iOS
EMDN: Z11040192
EMDN description: ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

Voluson Performance 16

Voluson Performance 18, Voluson Performance 16

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278910493
Basic UDI-DI: 08406821BUG005126Y
Reference: Voluson Performance 16 / 5957171
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Voluson Performance 18

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278910509
Basic UDI-DI: 08406821BUG005126Y
Reference: Voluson Performance 18 / 5957172
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Vivid Pioneer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Vingmed Ultrasound AS
Manufacturer SRN: NO-MF-000000553
UDI-DI: 00195278916938
Basic UDI-DI: 08406821BUG005397L
Reference: GN000100
EMDN: Z11040102
EMDN description: CARDIOLOGY ULTRASOUND SCANNERS
First on market country: Norway
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

HDi Bed Mount

HDi Accessories

Class IMDR 2017/745On the market

Manufacturer: ACIST Medical Systems, Inc.
Manufacturer SRN: US-MF-000010784
UDI-DI: 10841716102636
Basic UDI-DI: 08417161000009G5
Reference: 018196
EMDN: Z11049080
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: ACIST Europe BV
Last updated: 30.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

VirtuTRAX Instrument Navigator

Electromagnetic Tracking – Tools for Virtual Tracking

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
Manufacturer SRN: US-MF-000008229
UDI-DI: 00841436100892
Basic UDI-DI: 0841436101TD103DLF
Reference: 5350925
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: Germany
Authorised representative: MPS Medical Product Service GmbH
Last updated: 30.07.2026 20:05

Manufacturer products Authorised representative products Authorised representative actors View details

Curamor

KX07

Class IIaMDDOn the marketContains latexSingle use

Manufacturer: Karex Industries Sdn. Bhd.
Manufacturer SRN: MY-MF-000001247
UDI-DI: 19556564094965
Basic UDI-DI: B-19556564094965
Reference: KX07
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Aptor

KX07

Class IIaMDDOn the marketContains latexSingle use

Manufacturer: Karex Industries Sdn. Bhd.
Manufacturer SRN: MY-MF-000001247
UDI-DI: 19556564084683
Basic UDI-DI: B-19556564084683
Reference: KX07
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: Spain
Authorised representative: Advena Limited
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

ExactVu High Resolution Micro-Ultrasound System

EV-SYS-220

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Exact Imaging Inc.
Manufacturer SRN: CA-MF-000004363
UDI-DI: 00628055481010
Basic UDI-DI: 62805548162805548101055
Reference: EV-SYS-220
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

PMH Gel conductor ultrasonido

Ultrasound Gels

Class IMDR 2017/745On the marketSingle use

Manufacturer: AROM, S.A.
Manufacturer SRN: ES-MF-000043657
UDI-DI: 08430301900013
Basic UDI-DI: 841075701Ar16027J
Reference: 96646
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 23:17

Manufacturer products View details

SONDA WIFI LIN. FLEX 7,5MHZ L40 C/TABLET

SONDA WIFI LIN. FLEX CON TABLET

Class IIaMDR 2017/745On the market

Manufacturer: VYGON ITALIA SRL
Manufacturer SRN: IT-PR-000012626
UDI-DI: 08059602737878
Basic UDI-DI: 805960273D01AD8-1Y5
Reference: AD8L114KS01
EMDN: Z11040299
EMDN description: ULTRASOUND PROBES – OTHER
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 23:16

Manufacturer products View details

VirtuTRAX Instrument Navigator

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
Manufacturer SRN: US-MF-000008229
UDI-DI: 00841436101936
Basic UDI-DI: 0841436101TD103DLF
Reference: 610-1080
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: -
Authorised representative: MPS Medical Product Service GmbH
Last updated: 29.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

VirtuTRAX Instrument Navigator

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
Manufacturer SRN: US-MF-000008229
UDI-DI: 00841436121583
Basic UDI-DI: 0841436101TD103DLF
Reference: 620-127
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: -
Authorised representative: MPS Medical Product Service GmbH
Last updated: 29.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Sonosite PX

SONOSITE PX ULTRASOUND SYSTEM

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Fujifilm Sonosite, Inc.
Manufacturer SRN: US-MF-000001075
UDI-DI: 00841517112424
Basic UDI-DI: 08415171PX8P
Reference: P25000-61
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: Fujifilm Sonosite B.V.
Last updated: 29.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Sonosite PX

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Fujifilm Sonosite, Inc.
Manufacturer SRN: US-MF-000001075
UDI-DI: 00841517112561
Basic UDI-DI: 08415171PX8P
Reference: P25000-60
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: -
Authorised representative: Fujifilm Sonosite B.V.
Last updated: 29.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details