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Active filter:EMDN:Z12160385

7 device results listed.

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rezūm™

Rezum Delivery Device

Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729992554
Basic UDI-DI: 01915060000000000000379NN
Reference: 50737338-001
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

rezūm™

Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729996996
Basic UDI-DI: 01915060000000000000379NN
Reference: M006D2201-0031
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 30.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sonablate Insertion Pack

Sonablate HIFU consumables

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-PR-000045638
UDI-DI: 00850071153071
Basic UDI-DI: 00850071153HIFUpackUS
Reference: 404-13500-0001
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:35

Manufacturer products View details

Water Path Kit

Sonablate HIFU consumables

Class IMDR 2017/745On the marketSingle use

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-MF-000012164
UDI-DI: 00850071153064
Basic UDI-DI: 00850071153HIFUkitsX2
Reference: E01017AST61
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Water Path Kit

Class IMDR 2017/745On the marketSingle use

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-MF-000012164
UDI-DI: 00850071153088
Basic UDI-DI: 00850071153HIFUkitsX2
Reference: 411-12017-0001
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Sonablate Insertion Pack

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-PR-000045638
UDI-DI: 00850071153095
Basic UDI-DI: 00850071153HIFUpackUS
Reference: 404-14500-0003
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 01:43

Manufacturer products View details

O-Ring Applicator Tool

Class IMDR 2017/745On the marketSingle use

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-MF-000012164
UDI-DI: 00850071153101
Basic UDI-DI: 00850071153HIFUkitsX2
Reference: 302-08119-1002
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details