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X-DRS Mobile Elite

Class IIbMDR 2017/745On the market

Manufacturer: EXAMION GmbH
Manufacturer SRN: DE-PR-000019918
UDI-DI: 04066353008007
Basic UDI-DI: 4066353EXMobileXRaySysXD
Reference: SY.000130
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 23:23

Manufacturer products View details

H1074X

Class IIbNot specifiedOn the marketActive device

Manufacturer: Hangzhou Kailong Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000030241
UDI-DI: 06971564631099
Basic UDI-DI: 697156463XRTATL
Reference: H1074X-1.0/2.0-125-V3
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

LumbarMR

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GLEAMER
Manufacturer SRN: FR-MF-000011358
UDI-DI: 03770020839146
Basic UDI-DI: 377002083900007AS
Reference: LumbarMR
EMDN: Z11039092
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

Manufacturer products View details

LungCT

LungCT/BoneCT

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GLEAMER
Manufacturer SRN: FR-MF-000011358
UDI-DI: 03770020839122
Basic UDI-DI: 37700208390006L2
Reference: LungCT
EMDN: Z11039082
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

Manufacturer products View details

BreastView

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GLEAMER
Manufacturer SRN: FR-MF-000011358
UDI-DI: 03770020839115
Basic UDI-DI: 377002083900004AL
Reference: BreastView
EMDN: Z11039082
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

Manufacturer products View details

BoneView

BoneView / ChestView

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GLEAMER
Manufacturer SRN: FR-MF-000011358
UDI-DI: 03770020839061
Basic UDI-DI: 377002083900003AJ
Reference: BoneView
EMDN: Z11039082
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:57

Manufacturer products View details

CT Exprés Multi Patient Set

CT Exprès Disposables

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ACIST Medical Systems, Inc.
Manufacturer SRN: US-MF-000010784
UDI-DI: 10841716103954
Basic UDI-DI: 08417161000012FS
Reference: 640061
EMDN: Z11039085
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES
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

VeraPro AngioTouch HiFi 165

VeraPro

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: ACIST Medical Systems, Inc.
Manufacturer SRN: US-MF-000010784
UDI-DI: 10841716103800
Basic UDI-DI: 08417161000013FU
Reference: 018805
EMDN: Z11039085
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES
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

ACIST CVi A2000

014612

Class IIaMDR 2017/745On the marketAdministering medicineSterile

Manufacturer: ACIST Medical Systems, Inc.
Manufacturer SRN: US-MF-000010784
UDI-DI: 10841716103152
Basic UDI-DI: 08417161000002FP
Reference: 014612
EMDN: Z11039085
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES
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

omniTRAX™ Active Patient Tracker Starter Kit

Electromagnetic Tracking – Tools for Automated Image Fusion (Omnitrax MR)

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
Manufacturer SRN: US-MF-000008229
UDI-DI: 00841436110952
Basic UDI-DI: 0841436101TD103C2NR
Reference: 5670091
EMDN: Z11039099
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER
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

Starter Kit

Electromagnetic Tracking – Tracking Tools (Endocavity Tracking Brackets)

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: 00841436109338
Basic UDI-DI: 0841436101TD103A2dUH
Reference: H4908NF
EMDN: Z11039099
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER
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

omniTRAX Patient Tracker Starter Kit

Electromagnetic Tracking – Tools for Automated Image Fusion (Omnitrax CT)

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
Manufacturer SRN: US-MF-000008229
UDI-DI: 00841436101042
Basic UDI-DI: 0841436101TD103C1NP
Reference: 5438658
EMDN: Z11039099
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER
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

Tracking Bracket Starter Kit

Electromagnetic Tracking – Tracking Tools (Tracking Brackets)

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: 00841436100281
Basic UDI-DI: 0841436101TD103A2bUD
Reference: 10441184
EMDN: Z11039099
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: MPS Medical Product Service GmbH
Last updated: 30.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

OptiVantage Dual-Head CT Contrast Delivery System

OptiVantage

Class IIbMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: Liebel-Flarsheim Company, LLC
Manufacturer SRN: US-MF-000002605
UDI-DI: 10746190005902
Basic UDI-DI: 0746190L000035Q
Reference: 849101
EMDN: Z11039014
EMDN description: MULTIPLE CONTRAST AGENT INJECTORS
First on market country: France
Authorised representative: Guerbet
Last updated: 30.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

VacuDAP - OEM duo