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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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25 device results listed.

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Allia IGS 3

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278934543
Basic UDI-DI: 08406821BUG0052273
Reference: 5969355
EMDN: Z11030102
EMDN description: STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES
First on market country: Italy
Authorised representative: GE Medical Systems SCS
Last updated: 04.08.2026 20:54

Manufacturer products Authorised representative products Authorised representative actors View details

00195278577092

XR6000

Class IIbMDDOn the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278577092
Basic UDI-DI: B-00195278577092
Reference: 5463900PCM
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: Türkiye
Authorised representative: GE Medical Systems SCS
Last updated: 01.08.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

OEC One CFD

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00840682145541
Basic UDI-DI: 8406821BUG00297HX
Reference: 7999000PCM
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

OEC One ASD

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278685001
Basic UDI-DI: 8406821BUG00455HR
Reference: OEC One ASD
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Pace Select

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278526892
Basic UDI-DI: 8406821BUG00327HF
Reference: B2604CAB
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: Romania
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

OEC Elite MiniView

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278502582
Basic UDI-DI: 8406821BUG00405HA
Reference: 5730328
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

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

NM/CT 870 DR

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278672704
Basic UDI-DI: 8406821BUG00349HR
Reference: H2402BG
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA 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

Xeleris V Processing & Review System

Xeleris V Processing and Review System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278672728
Basic UDI-DI: 8406821BUG00380HK
Reference: 5927911-1
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - 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

Xeleris 4 DR Processing and Review Workstation

Xeleris 4 DR Processing & Review Workstation

Class IIaMDDOn the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278894687
Basic UDI-DI: B-00195278894687
Reference: 5782764-1
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - 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

Brivo XR575

Class IIbMDDOn the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278448736
Basic UDI-DI: B-00195278448736
Reference: 5424711PCM
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 13:24

Manufacturer products Authorised representative products Authorised representative actors View details

Aurora

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00198953017616
Basic UDI-DI: 08406821BUG005717G
Reference: H2412AL, H2412AN
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: Ireland
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

00195278913814

Definium Tempo Select

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278913814
Basic UDI-DI: 08406821BUG005197E
Reference: B2400UDI
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

00195278913807

Definium Pace Select ET

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278913807
Basic UDI-DI: 08406821BUG005206X
Reference: B2600UDI
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Tempo Select

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00198953056158
Basic UDI-DI: 08406821BUG005197E
Reference: B4400UDI
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 09.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Pace Select ET

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00198953056103
Basic UDI-DI: 08406821BUG005206X
Reference: B4600UDI
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 09.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

Optima XR646 HD

Class IIbMDDOn the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00840682142175
Basic UDI-DI: B-00840682142175
Reference: Optima XR646 HD
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 05.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

NM/CT 850

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00840682142144
Basic UDI-DI: B-00840682142144
Reference: 5804394 PCM
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 05.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

NM/CT 860

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00840682142137
Basic UDI-DI: B-00840682142137
Reference: 5804395 PCM
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: Poland
Authorised representative: GE Medical Systems SCS
Last updated: 05.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details