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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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74 device results listed.

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TomoScanner

Class IMDR 2017/745On the marketActive device

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946499
Basic UDI-DI: 0850019946WATERTANKU9
Reference: 91750
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Reconstruction Jig (Small)

Class IMDR 2017/745On the market

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946574
Basic UDI-DI: 0850019946RECONJIGXH
Reference: 91285
EMDN: Z11019080
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Exradin A10

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946581
Basic UDI-DI: 0850019946EXRADINICL5
Reference: 92702
EMDN: Z11019082
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Exradin P11

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946598
Basic UDI-DI: 0850019946EXRADINICL5
Reference: 92703
EMDN: Z11019082
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

IMSure

Class IMDR 2017/745Not intended for EU marketActive device

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946604
Basic UDI-DI: 08665620002IMSURE8S
Reference: 91355
EMDN: Z11010182
EMDN description: LINEAR ACCELERATORS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

MAX Elite Electrometer

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946628
Basic UDI-DI: 0850019946ELECTROMETER7L
Reference: 90025
EMDN: Z11019082
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

LUCY EA Phantom

Class IMDR 2017/745On the market

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946635
Basic UDI-DI: 0850019946LUCYPHANTOMP4
Reference: 91600
EMDN: Z11019080
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

LUCY ThorX Phantom

Class IMDR 2017/745On the market

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946659
Basic UDI-DI: 0850019946LUCYPHANTOMP4
Reference: 91630
EMDN: Z11019080
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Exradin A30

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946666
Basic UDI-DI: 0850019946EXRADINICL5
Reference: 92727
EMDN: Z11019082
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

QA BeamChecker Pro

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946697
Basic UDI-DI: 0850019946QACHECKER94
Reference: 90503
EMDN: Z11019099
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

ISOCube Phantom

Class IMDR 2017/745On the market

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00850019946710
Basic UDI-DI: 0850019946SDVPHANTOMNS
Reference: 91640
EMDN: Z11019080
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 22.06.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

DoseVieew 3D

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00866562000205
Basic UDI-DI: 08665620002DOSEVIEWZD
Reference: 92260
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 21.06.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

IMSure QA

Class IMDR 2017/745On the marketActive device

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00866562000229
Basic UDI-DI: 08665620002IMSURE8S
Reference: 91326
EMDN: Z11010182
EMDN description: LINEAR ACCELERATORS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 21.06.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

IVB 1000

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Standard Imaging, Inc.
Manufacturer SRN: US-MF-000009855
UDI-DI: 00866562000250
Basic UDI-DI: 08665620002WELLCHAMBERAQ
Reference: 90009
EMDN: Z11010380
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Hoff & Lowendahl AB
Last updated: 21.06.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details