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Amadeo M-DR mini

Class IIbMDR 2017/745On the market

Manufacturer: Oehm und Rehbein GmbH
Manufacturer SRN: DE-PR-000037490
UDI-DI: 04250802900008
Basic UDI-DI: 42508029AM1100XZ
Reference: AM1100
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 00:47

Manufacturer products View details

Pre-waxed Brachytherapy needle, 17 G with Gold Marker 1,2 x 5 mm, set of 3 pieces

Brachytherapie-Nadeln mit Goldmarker

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: Primed Halberstadt Medizintechnik GmbH
Manufacturer SRN: DE-MF-000004967
UDI-DI: 04250203247504
Basic UDI-DI: 42502032PRI0704V
Reference: 24106
EMDN: Z11010385
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:54

Manufacturer products View details

Gold Marker 1,0 x 5 mm (Au 999), set of 3 pieces

Goldmarker

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: Primed Halberstadt Medizintechnik GmbH
Manufacturer SRN: DE-MF-000004967
UDI-DI: 04250203225298
Basic UDI-DI: 42502032PRI0714X
Reference: 24122
EMDN: Z11010385
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:54

Manufacturer products View details

ML4-20VN-D

Class IIaNot specifiedOn the marketActive device

Manufacturer: GE Parallel Design, Inc.
Manufacturer SRN: US-MF-000009295
UDI-DI: 00195278002730
Basic UDI-DI: 8406821BUG00337HJ
Reference: 5838851
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
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

Spectral Bone Marrow

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278630377
Basic UDI-DI: 8406821BUG00412H7
Reference: 5929650
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Spectral Color Overlay

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278630384
Basic UDI-DI: 8406821BUG00413H9
Reference: 5929649
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Apex Expert

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278633149
Basic UDI-DI: 8406821BUG00213GX
Reference: Revolution Apex Expert
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
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

Voluson Signature 20

Voluson Signature 20, Voluson Signature 18

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278633804
Basic UDI-DI: 8406821BUG00309HD
Reference: Voluson Signature 20 / 5926010
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 Signature 18

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278633811
Basic UDI-DI: 8406821BUG00309HD
Reference: Voluson Signature 18 / 5928500
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

IGS 5

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278637987
Basic UDI-DI: 8406821BUG00099HR
Reference: 5929884
EMDN: Z11030102
EMDN description: STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

3DXR

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278640437
Basic UDI-DI: 8406821BUG00343HD
Reference: 5932304
EMDN: Z11030192
EMDN description: DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

Vscan Air

Vscan Air R2 for iOS, Vscan Air R2 for Android, Vscan Air R3 for iOS, Vscan Air R3 for Android

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Vingmed Ultrasound AS
Manufacturer SRN: NO-MF-000000553
UDI-DI: 00195278640550
Basic UDI-DI: 8406821BUG00375HS
Reference: Vscan Air R2 for iOS
EMDN: Z11040192
EMDN description: ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
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: 00195278640567
Basic UDI-DI: 8406821BUG00375HS
Reference: Vscan Air R2 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: 00195278640574
Basic UDI-DI: 8406821BUG00375HS
Reference: Vscan Air R2 upgrade
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

Universal Viewer 8.1

Universal Viewer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Healthcare
Manufacturer SRN: US-MF-000001862
UDI-DI: 00195278644039
Basic UDI-DI: 8406821BUG00216H5
Reference: 5865733-001
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

RAB7-D

5929364

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278644152
Basic UDI-DI: 8406821BUG00350HA
Reference: H48062AN
EMDN: Z110402010202
EMDN description: CURVILINEAR TRANSCUTANEOUS MULTIDIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY)
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA PET/MR

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278648877
Basic UDI-DI: 8406821BUG00307H9
Reference: SIGNA PET/MR
EMDN: Z11020701
EMDN description: MRI/PET SYSTEMS
First on market country: France
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 SL

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Vingmed Ultrasound AS
Manufacturer SRN: NO-MF-000000553
UDI-DI: 00195278660701
Basic UDI-DI: 8406821BUG00374HQ
Reference: Vscan Air SL
EMDN: Z110402010301
EMDN description: TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

00195278664600

LOGIQ Totus

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278664600
Basic UDI-DI: 8406821BUG00347HM
Reference: LOGIQ Totus/H46202LA
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Greece
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

48CH Head Coil

3.0T 48CH Head Coil

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Coils
Manufacturer SRN: US-MF-000001664
UDI-DI: 00195278665249
Basic UDI-DI: 8406821BUG00313H4
Reference: 5930100
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details