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Aerial couchtop for proton therapy

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05401172006381
Basic UDI-DI: 54200287005357
Reference: 25000/53
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 15:44

Manufacturer products View details

AIO 3.0 - Indexed prone head support

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028737972
Basic UDI-DI: 5420028700304T
Reference: 38226
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 15:37

Manufacturer products View details

Cranial 4Pi Headrest Inlay Standard

Cranial 4PI Headrest Inlays

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481146795
Basic UDI-DI: 4056481Cranial4PiHeadShJ4
Reference: 43446C
EMDN: Z11019080
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 15:26

Manufacturer products View details

Cranial 4Pi Stereotactic Mask (1 pc)

Cranial 4Pi Masks

Class IMDR 2017/745On the market

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481146917
Basic UDI-DI: 4056481Cranial4PiMasksEA
Reference: 43450-01A
EMDN: Z11019080
EMDN description: VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 15:26

Manufacturer products View details

AIO 3.0 – Base plate CFL – without leg s

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028737576
Basic UDI-DI: 5420028700304T
Reference: 38014
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 15:15

Manufacturer products View details

AIO 3.0 LOXON™ Set for 54cm base plates

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028737095
Basic UDI-DI: 5420028700304T
Reference: 38225
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 15:02

Manufacturer products View details

Atlas SPEEDER Head/Neck

MRI RF Coils

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Quality Electrodynamics, LLC
Manufacturer SRN: US-MF-000001417
UDI-DI: 00814848020560
Basic UDI-DI: 081484802RFCOILBV
Reference: Q7000126
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 14:58

Manufacturer products Authorised representative products Authorised representative actors View details

AIO 3.0 - Breast & lung board grip pole

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028736647
Basic UDI-DI: 5420028700304T
Reference: 38238
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 14:52

Manufacturer products View details

DefiniumTM XR120, GreenON

Medical Image Processing Unit (Flat Panel Detector)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Rayence Co., Ltd.
Manufacturer SRN: KR-MF-000014713
UDI-DI: 08800018600498
Basic UDI-DI: 880001861417WCCM9
Reference: 1012WCC
EMDN: Z11031180
EMDN description: SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: VATECH GLOBAL FRANCE SARL
Last updated: 23.09.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

AIO 3.0 SBRT Pressure System Bridge - Lo

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028735718
Basic UDI-DI: 5420028700304T
Reference: 38222
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 14:43

Manufacturer products View details

AIO 3.0 Indexing Knob - Caudal

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028735671
Basic UDI-DI: 5420028700304T
Reference: 38107/4
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 14:30

Manufacturer products View details

AIO 3.0 Indexing Knob - Cranial

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028735626
Basic UDI-DI: 5420028700304T
Reference: 38107/2
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 14:19

Manufacturer products View details

AIO 3.0 - Belly & Pelvic Board

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028735527
Basic UDI-DI: 5420028700304T
Reference: 38119
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 14:09

Manufacturer products View details

Medical Imaging Printer

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Tianjin KangMeiTu YunYi Medical Instruments Co., LTD
Manufacturer SRN: CN-MF-000057352
UDI-DI: 16980345758013
Basic UDI-DI: 698034575kmt800FA
Reference: KMT8219
EMDN: Z11079005
EMDN description: PRINTING MACHINES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 23.09.2026 14:06

Manufacturer products Authorised representative products Authorised representative actors View details

AIO 3.0 gen acc – grip pole short

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028735336
Basic UDI-DI: 5420028700304T
Reference: 38223
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 13:59

Manufacturer products View details

KP Cam

KP Smart

Class IMDR 2017/745On the marketActive device

Manufacturer: Guilin Kevin Peter Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022934
UDI-DI: 06975384334055
Basic UDI-DI: 697538433996PW
Reference: /
EMDN: Z11030402
EMDN description: SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY
First on market country: Ireland
Authorised representative: MedNet EC-REP C IIb GmbH
Last updated: 23.09.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

AIO 3.0 - Prone Breast Board

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028733028
Basic UDI-DI: 5420028700304T
Reference: 38219
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 13:49

Manufacturer products View details

AIO 3.0 SBRT Pressure System Bridge - Hi

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028732410
Basic UDI-DI: 5420028700304T
Reference: 38218
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 13:39

Manufacturer products View details

AIO 3.0 SBRT conversion parts for SBRT c

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028732298
Basic UDI-DI: 5420028700304T
Reference: 38217
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 13:30

Manufacturer products View details

AIO 3.0 - Breast & Lung Board - 0 degree

Base Plate

Class IMDR 2017/745On the marketSingle use

Manufacturer: Orfit Industries
Manufacturer SRN: BE-MF-000007872
UDI-DI: 05420028732281
Basic UDI-DI: 5420028700304T
Reference: 38117
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 13:19

Manufacturer products View details