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00195278487414

LOGIQ E10s

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278487414
Basic UDI-DI: 8406821BUG00033GT
Reference: LOGIQ E10s R2 to R3 UPG / 5874847
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Hero

Class IIaMDR 2017/745On the marketActive deviceContains latex

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278486813
Basic UDI-DI: 8406821BUG00278HT
Reference: SIGNA Hero
EMDN: Z11050105
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

IGS 5

Allia

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278485144
Basic UDI-DI: 8406821BUG00099HR
Reference: 5872892
EMDN: Z11030102
EMDN description: STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:17

Manufacturer products View details

00195278473028

Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278473028
Basic UDI-DI: 8406821BUG00209H8
Reference: Voluson Signature to BT22 UPG / 5881172
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

00195278473011

Voluson P8, Voluson P6

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278473011
Basic UDI-DI: 8406821BUG00210GR
Reference: Voluson Performance to BT22 UPG / 5881175
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution CT ES with Apex edition

Apex Edition

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278471277
Basic UDI-DI: 8406821BUG00154H8
Reference: Revolution CT ES with Apex edition
EMDN: Z11030607
EMDN description: COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Apex Select

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278469700
Basic UDI-DI: 8406821BUG00213GX
Reference: Power Xtream: B7919QT; Power Pro: B7919QS
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

RT Refresh Package

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278466488
Basic UDI-DI: 8406821BUG00215H3
Reference: B79612DA, B79602DA
EMDN: Z11030603
EMDN description: COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

00195278464668

LOGIQ P8, LOGIQ P9, LOGIQ P10

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278464668
Basic UDI-DI: 8406821BUG00211GT
Reference: LOGIQ P10 R4.5 HD/H42932LE
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Spain
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Tempo

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278118356
Basic UDI-DI: 8406821BUG00192HG
Reference: B2401CAB
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Tempo Pro

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278070265
Basic UDI-DI: 8406821BUG00193HJ
Reference: B2402CAB
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

VDX Next System 4343VW STD

VDX Next System

Class IIbMDR 2017/745On the market

Manufacturer: Villa Sistemi Medicali S.p.A.
Manufacturer SRN: IT-PR-000027254
UDI-DI: 08057737121487
Basic UDI-DI: 805773712FT2519P
Reference: 8785V05000
EMDN: Z11039021
EMDN description: RADIOGRAPHY VIDEO ACQUISITION SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:14

Manufacturer products View details

MX/1000 FP21

MX/1000

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.T.S. Applicazione Tecnologie Speciali s.r.l.
Manufacturer SRN: IT-MF-000010734
UDI-DI: 08055186671010
Basic UDI-DI: 805518667MX/1000D9
Reference: 93 02 000
EMDN: Z11039006
EMDN description: RADIOLOGY CONTROL UNITS
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:13

Manufacturer products View details

OMNISCOP DReam

ARCO FP

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.T.S. Applicazione Tecnologie Speciali s.r.l.
Manufacturer SRN: IT-MF-000010734
UDI-DI: 08055186670211
Basic UDI-DI: 805518667FPVP
Reference: 74 09 000-1; 74 11 000-1
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:13

Manufacturer products View details

FDX Visionary CS

ARCO FP-S

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.T.S. Applicazione Tecnologie Speciali s.r.l.
Manufacturer SRN: IT-MF-000010734
UDI-DI: 08055186670150
Basic UDI-DI: 805518667FP-SFH
Reference: 95 05 000
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 22:13

Manufacturer products View details

CS3101

Ceiling

Class IMDR 2017/745On the market

Manufacturer: General Medical Merate S.p.A.
Manufacturer SRN: IT-MF-000023169
UDI-DI: 08054890480369
Basic UDI-DI: 805489048PENQ7
Reference: CS3101
EMDN: Z11030502
EMDN description: CEILING STANDS FOR RADIOLOGICAL EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:13

Manufacturer products View details

CT160F

Table for RAD rooms

Class IMDR 2017/745On the market

Manufacturer: General Medical Merate S.p.A.
Manufacturer SRN: IT-MF-000023169
UDI-DI: 08054890480215
Basic UDI-DI: 805489048TRDRE
Reference: CT160F
EMDN: Z11030503
EMDN description: PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:13

Manufacturer products View details

WST-DX

Wall Stand units

Class IMDR 2017/745On the market

Manufacturer: General Medical Merate S.p.A.
Manufacturer SRN: IT-MF-000023169
UDI-DI: 08054890480130
Basic UDI-DI: 805489048TLRRQ
Reference: WST-DX
EMDN: Z11030506
EMDN description: TELERADIOGRAPHS
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:13

Manufacturer products View details

LILYUM

ANALOG MAMMOGRAPHY

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Metaltronica SpA
Manufacturer SRN: IT-MF-000014684
UDI-DI: 08052405210043
Basic UDI-DI: 805240521ANALOGICGV
Reference: M-LILYUM
EMDN: Z11030201
EMDN description: CONVENTIONAL MAMMOGRAPHY SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:12

Manufacturer products View details

SPY-PHI Articulating Arm, Main Arm

AA-0100

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Axcess Surgical Innovations LLC.
Manufacturer SRN: US-MF-000014666
UDI-DI: 00810007560007
Basic UDI-DI: 81000756AXS00016J
Reference: HH1001
EMDN: Z119099
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Axcess Surgical Innovations B.V.
Last updated: 31.07.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details