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Afterloader Basic Device GammaMedplus 230 Volt, Series iX

GammaMedplus iX / GammaMedplus 3/24 iX

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00816389020399
Basic UDI-DI: 089947500201002PE
Reference: GM84000280
EMDN: Z11010301
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Applicator and Dilator for Proctoscope ø30 mm

MAASTRO Rectal Applicator Set

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00816389020207
Basic UDI-DI: 089947500201005PL
Reference: GM11014410
EMDN: Z11010380
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Small fixed template, size 100 mm

Advanced Breast Template System

Class IIaMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563023206
Basic UDI-DI: 089947500201029Q2
Reference: AL07376000
EMDN: Z11010380
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Shielding for cone, ø 30-45mm diameter, with fixation

Surface Applicator Set

Class IIaMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022711
Basic UDI-DI: 089947500201055Q3
Reference: GM11003580
EMDN: Z11010380
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Surface cone inset ø 20 mm, round

Surface cone inset

Class IIaMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022698
Basic UDI-DI: 089947500201124PV
Reference: GM11003680
EMDN: Z11010380
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Pushing device for implant needle, 1.7 mm diameter

Pushing Devices

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022667
Basic UDI-DI: 089947500201103PM
Reference: GM11003040
EMDN: Z11010380
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Ovoids for 25 mm spread, pair

Ovoids

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022575
Basic UDI-DI: 089947500201101PH
Reference: GM11000920
EMDN: Z11010380
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:03

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3D-FSD interstitial ovoid pair for 25 mm spread, with 6 needle guide holes each ovoid

Interstitial ovoids and needle collector pair

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022537
Basic UDI-DI: 089947500201204PU
Reference: GM11010720
EMDN: Z11010380
EMDN description: BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Integrated Conical Collimator Verification and Interlock System (ICVI) Conical Collimator Set

Integrated Conical Collimator Verification and Interlock System (ICVI)

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00899475002585
Basic UDI-DI: 089947500200112PF
Reference: 10006251933
EMDN: Z11010780
EMDN description: RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

IDENTIFY

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00858086006801
Basic UDI-DI: 089947500200113PH
Reference: IDENTIFY 3.0
EMDN: Z119099
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

TrueBeam

TrueBeam-TrueBeam STx-Edge and VitalBeam

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableDirect markingEMRMeasuring function

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00858086006771
Basic UDI-DI: 089947500200122PJ
Reference: TrueBeam 4.0
EMDN: Z11010103
EMDN description: MULTI AND HIGH ENERGY LINEAR ACCELERATORS
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

Wedge Set Lower, 30 CM

Collimators Accessories

Class IMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00858086006467
Basic UDI-DI: 089947500200138PZ
Reference: 10004249710
EMDN: Z11010180
EMDN description: LINEAR ACCELERATORS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

HeadFrame Kit w/20 Short + 20 Long Head Screws

HeadFrame

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00858086006306
Basic UDI-DI: 089947500200111PD
Reference: P1006805005
EMDN: Z11010780
EMDN description: RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

VARIAN APPLICATOR ASSY,10X6 CM 65.4 OPTIONAL UPGRADE

Electron Applicator

Class IMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00858086006139
Basic UDI-DI: 089947500200137PX
Reference: 886800156
EMDN: Z11010199
EMDN description: LINEAR ACCELERATORS – OTHER
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Halcyon

Halcyon, Ethos Radiotherapy System

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00857235006075
Basic UDI-DI: 089947500200108PQ
Reference: Halcyon 4.0
EMDN: Z11010101
EMDN description: SINGLE ENERGY LINEAR ACCELERATORS
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Varian Verification System

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00856104006178
Basic UDI-DI: 089947500200125PQ
Reference: Varian Verification System 1.2
EMDN: Z11010182
EMDN description: LINEAR ACCELERATORS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Varian Treatment

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00856104006000
Basic UDI-DI: 089947500200123PL
Reference: Varian Treatment 13.0
EMDN: Z11010401
EMDN description: RADIOTHERAPY TREATMENT PLANNING SYSTEMS
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Ethos Treatment Management

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00856100006271
Basic UDI-DI: 089947500200117PR
Reference: Ethos Treatment Management 2.1
EMDN: Z11010492
EMDN description: RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Ethos Treatment Planning

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00856100006264
Basic UDI-DI: 089947500200121PG
Reference: Ethos Treatment Planning 1.1
EMDN: Z11010401
EMDN description: RADIOTHERAPY TREATMENT PLANNING SYSTEMS
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Gating Reflector Block

Marker Blocks

Class IMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00856100006226
Basic UDI-DI: 089947500200109PS
Reference: Gating Reflector Block 1.0
EMDN: Z119080
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details