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ACIST Pro Diagnostic System

ACIST Pro System

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineDirect markingMeasuring function

Manufacturer: ACIST Medical Systems, Inc.
Manufacturer SRN: US-MF-000010784
UDI-DI: 10841716103084
Basic UDI-DI: 08417161000014FW
Reference: 019304
EMDN: Z11039013
EMDN description: ANGIOGRAPHIC INJECTORS
First on market country: Netherlands
Authorised representative: ACIST Europe BV
Last updated: 16.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

ACIST Pro Hemodynamic Cable

ACIST Pro

Class IMDR 2017/745On the market

Manufacturer: ACIST Medical Systems, Inc.
Manufacturer SRN: US-MF-000010784
UDI-DI: 10841716103008
Basic UDI-DI: 08417161000016G2
Reference: 019335
EMDN: Z11039085
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: ACIST Europe BV
Last updated: 16.07.2026 05:16

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Multi-Modality Fiducial Marker

6000-090-060

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: IZI Medical Products
Manufacturer SRN: US-MF-000029992
UDI-DI: 00815212021664
Basic UDI-DI: 081521202MMmarkerLC
Reference: 6000-090-060
EMDN: Z11039085
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: ILUMARK GmbH
Last updated: 16.07.2026 04:18

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Po-ny Mon CF-988 W

CF-988 W

Class IMDR 2017/745On the marketActive deviceContains latexDirect marking

Manufacturer: Meiliguang (MLG) Medical Instrument (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000043424
UDI-DI: 06977586940379
Basic UDI-DI: 0697758694988WAS
Reference: CF-988 W
EMDN: Z11039010
EMDN description: PHOTO CAMERAS
First on market country: Italy
Authorised representative: Po-ny S.R.L.
Last updated: 16.07.2026 01:16

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MEDRAD® Avanta Fluid Management Injection System

MEDRAD® Avanta Fluid Management System

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Bayer Medical Care Inc.
Manufacturer SRN: US-MF-000007050
UDI-DI: 00616258021447
Basic UDI-DI: 0616258TFCN-0060Q8
Reference: AVANTA BASE SYSTEM
EMDN: Z11039013
EMDN description: ANGIOGRAPHIC INJECTORS
First on market country: Netherlands
Authorised representative: Bayer Medical Care B.V.
Last updated: 16.07.2026 01:04

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MEDRAD® Stellant CT Injection System with Certegra Workstation

Class IIbMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: Bayer Medical Care Inc.
Manufacturer SRN: US-MF-000007050
UDI-DI: 00616258020860
Basic UDI-DI: 0616258TFCN-0082IIbZ3
Reference: SCT-310
EMDN: Z11039013
EMDN description: ANGIOGRAPHIC INJECTORS
First on market country: Netherlands
Authorised representative: Bayer Medical Care B.V.
Last updated: 16.07.2026 01:04

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MEDRAD® Mark 7 Arterion Injection System

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineSingle useSterile

Manufacturer: Bayer Medical Care Inc.
Manufacturer SRN: US-MF-000007050
UDI-DI: 00616258006994
Basic UDI-DI: 0616258TFCN-0081IIbYU
Reference: VF HC
EMDN: Z11039013
EMDN description: ANGIOGRAPHIC INJECTORS
First on market country: Netherlands
Authorised representative: Bayer Medical Care B.V.
Last updated: 16.07.2026 01:04

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LUMINOS Q.namix R

MDR_16_II b_ERLN H 127_Fluoro_digital

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869993973
Basic UDI-DI: 0405686901994WS
Reference: 11574002
EMDN: Z11039009
EMDN description: FLUOROSCOPY DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

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Article 22 Comb. CIARTIC

MDR_SPPP_01_IIb_FOR_Combination_CIATRIC

Class IIbMDR 2017/745On the market

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-PR-000020469
UDI-DI: 04056869956107
Basic UDI-DI: 0405686902120UU
Reference: 11108425
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 00:38

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LUMINOS Impulse

MDR_16_II b_SHA NH_ACDV_FLOURO_DIGITAL_SSME_XP

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Shanghai Medical Equipment Ltd.
Manufacturer SRN: CN-MF-000013434
UDI-DI: 04056869281865
Basic UDI-DI: 0405686901997WY
Reference: 11506518
EMDN: Z11039009
EMDN description: FLUOROSCOPY DEVICES
First on market country: Germany
Authorised representative: Siemens Healthcare GmbH
Last updated: 16.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

CIARTIC Move

MDR_01_IIb_FOR_ACDV_CIARTIC Move

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869279619
Basic UDI-DI: 0405686901983WM
Reference: 11108130
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

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MOBILETT Elara Max

MDR_17_II b_ERLN H 127_Mobil_digital

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869154992
Basic UDI-DI: 0405686901982WK
Reference: 11107444
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

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Multitom Rax

MDR_16_II b_ERLN H 127_RF_combi

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869009179
Basic UDI-DI: 0405686901995WU
Reference: 10860700
EMDN: Z11039009
EMDN description: FLUOROSCOPY DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

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Uroskop Omnia Max

MDR_04_II b_ERLN H 127_Uro

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869008981
Basic UDI-DI: 0405686901984WP
Reference: 10762473
EMDN: Z11039009
EMDN description: FLUOROSCOPY DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

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CIOS SELECT

MDR_01_IIb_SHA_ACDV_Cios Select

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Siemens Shanghai Medical Equipment Ltd.
Manufacturer SRN: CN-MF-000013434
UDI-DI: 04056869267180
Basic UDI-DI: 0405686900121UG
Reference: 11515088
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Germany
Authorised representative: Siemens Healthcare GmbH
Last updated: 16.07.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

Article 22 Comb. Cios Select

MDR_SPPP_01_IIb_SHA_Combination_Cios Select

Class IIbMDR 2017/745On the marketNo EU rep

Manufacturer: Siemens Shanghai Medical Equipment Ltd.
Manufacturer SRN: CN-PR-000020466
UDI-DI: 04056869267142
Basic UDI-DI: 0405686900153UV
Reference: 11328304
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 00:10

Manufacturer products View details

Article 22 Comb. Cios

MDR_SPPP_01_IIb_FOR_Combination_Cios

Class IIbMDR 2017/745On the market

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-PR-000020469
UDI-DI: 04056869267135
Basic UDI-DI: 0405686900152UT
Reference: 11328303
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 00:10

Manufacturer products View details

Cios Alpha

MDR_01_IIb_FOR_ACDV_Cios Flow/Alpha/Spin (VA30)

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869153490
Basic UDI-DI: 0405686900147V2
Reference: 11105200
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:10

Manufacturer products View details

SD30C FPD

SD30C FPD+21

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: IDETEC SAS
Manufacturer SRN: FR-MF-000018489
UDI-DI: +G590SD30CFPD210B
Basic UDI-DI: ++G590SD30CFPDQS
Reference: SD30C FPD+21
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 21:21

Manufacturer products View details

Buck Hammer

Class IMDR 2017/745On the marketReusable

Manufacturer: MEHRISH INDUSTRIES PVT LTD
Manufacturer SRN: PK-MF-000031501
UDI-DI: G410M01011180
Basic UDI-DI: ++G410M0101118PN
Reference: M01-011-18
EMDN: Z11039080
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Romania
Authorised representative: ANTEX MEDI SOLUTION
Last updated: 15.07.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details