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IntelliBlate Microwave Ablation System Console

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000007453
UDI-DI: 00810563022278
Basic UDI-DI: 089947500200145PW
Reference: IB-CON
EMDN: Z12010902
EMDN description: ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Adapter pin for GYN templates

Kelowna GYN and Crook Prostate Templates

Class IIaMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022254
Basic UDI-DI: 089947500201144Q3
Reference: GM11012310
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

3D Interstitial Ring Applicator Set 90°

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022247
Basic UDI-DI: 089947500201135Q2
Reference: GM11010290
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

3D Interstitial Ring Applicator Set 60°

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022230
Basic UDI-DI: 089947500201134PY
Reference: GM11010190
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Fixation button kit 1 (red, blue, white) sterile

Fixation Buttons

Class IIaMDR 2017/745On the marketAnnex XVI applicableSingle useSterile

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022216
Basic UDI-DI: 089947500201117PY
Reference: GM11010360
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Allen key, 2.0 mm wrench size

Allen Wrench 2mm

Class IIaMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022209
Basic UDI-DI: 089947500201100PF
Reference: GM11000700
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Handle for lever

Universal Endometrial Applicator Set

Class IIaMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022094
Basic UDI-DI: 089947500201061PW
Reference: GM11009930
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Mould probe MR safe, 1.8 mm diameter x 320 mm, with mandrin (GM11010470)

Mould Probe MR Safe

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022087
Basic UDI-DI: 089947500201044PW
Reference: GM11002610
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Flexible fixation plate for gynaecological applicators

Flexible Fixation Device for Gynecological Applicators

Class IMDR 2017/745On the market

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563022070
Basic UDI-DI: 089947500201091Q7
Reference: GM11002130
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal

ISOLIS Cryoprobe

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000007453
UDI-DI: 00810563022032
Basic UDI-DI: 089947500200144PU
Reference: PC-2.1E
EMDN: Z120102
EMDN description: CRYOSURGERY EQUIPMENT
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Mandrin for 113 mm length

Mandrin

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563021998
Basic UDI-DI: 089947500201040PN
Reference: GM11010390
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin (GM11010450)

Interstitial Plastic Needles

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563021967
Basic UDI-DI: 089947500201048Q6
Reference: GM11014710
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Heyman capsule MR safe, 4 mm diameter x 17.5 mm length, with mandrin (GM11010470)

Heyman Packing Applicator Set

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563021929
Basic UDI-DI: 089947500201035PV
Reference: GM11005410
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Ring probe 90 (2021) °, 26 x 32 mm

Ring Applicator Set 90°

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563021905
Basic UDI-DI: 089947500201026PU
Reference: GM11001600
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Ring probe 60 (2021) °, 26 x 32 mm

Ring Applicator Set 60°

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563021882
Basic UDI-DI: 089947500201027PW
Reference: GM11001580
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 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Ring probe 45° (2021) , 26 x 32 mm

Ring Applicator Set 45°

Class IIaMDR 2017/745On the marketAnnex XVI applicable

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000001784
UDI-DI: 00810563021868
Basic UDI-DI: 089947500201046Q2
Reference: GM11001560
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 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

40um Tandem 2mL - INTL

TANDEM

Class IIIMDR 2017/745On the marketWell-established tech (possible)Administering medicineAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000007453
UDI-DI: 00810563021363
Basic UDI-DI: 089947500200141PN
Reference: 10420-TS0
EMDN: C010402020303
EMDN description: EMBOLISATION PARTICLES AND MICROSPHERES
First on market country: Netherlands
Safety summary (SSCP/SSP): P1067216 · Rev. 004-D
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

40um Embozene 1mL Colored - INTL

Embozene®Color-Advanced Microspheres

Class IIbMDR 2017/745On the marketWell-established tech (possible)Administering medicineAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000007453
UDI-DI: 00810563021165
Basic UDI-DI: 089947500200139Q3
Reference: 10410-S1
EMDN: C010402020303
EMDN description: EMBOLISATION PARTICLES AND MICROSPHERES
First on market country: Netherlands
Safety summary (SSCP/SSP): P1067215 · Rev. 004-D
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Urethral Warming Catheter Kit

Class IIaMDR 2017/745On the marketAnnex XVI applicableSingle useSterile

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000007453
UDI-DI: 00810563020977
Basic UDI-DI: 089947500200140PL
Reference: DP40-0141-106
EMDN: U010299
EMDN description: URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

8mm Cryoprobe

Straight Cryoprobe

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableSingle useSterile

Manufacturer: Varian Medical Systems, Inc.
Manufacturer SRN: US-MF-000007453
UDI-DI: 00810563020953
Basic UDI-DI: 089947500200134PR
Reference: DP35-0215-101
EMDN: Z120102
EMDN description: CRYOSURGERY EQUIPMENT
First on market country: Netherlands
Authorised representative: Siemens Healthineers Nederland B.V.
Last updated: 01.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details