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660 device results listed.

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AMULET Bellus II

MIS-1000

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410345438
Basic UDI-DI: 454741040100000000000498V
Reference: 04547410345438
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 24.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

BoneXpert

3.2

Class IMDDOn the market

Manufacturer: Visiana ApS
Manufacturer SRN: DK-MF-000029049
UDI-DI: D-574400661BONEXPERTH94K
Basic UDI-DI: B-574400661BONEXPERTH94K
Reference: 3.2
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:49

Manufacturer products View details

PMA.core

PMA.core 3.0

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Pathomation BV
Manufacturer SRN: BE-MF-000035661
UDI-DI: D-54199804460PMAcore34C59
Basic UDI-DI: B-54199804460PMAcore34C59
Reference: PMA.core 3.0
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 17.07.2026 02:47

Manufacturer products View details

Mirasol™ Manager

Class IIaMDDOn the market

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583110700
Basic UDI-DI: B-05020583110700
Reference: 11070
EMDN: Z11069001
EMDN description: BIOIMAGING PROCESSORS
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 16.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Xeleris V Processing & Review System

Xeleris V Processing and Review System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00198953246405
Basic UDI-DI: 8406821BUG00344HF
Reference: 6015087
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975781740022

002

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Jiangsu Fuhan Medical Industry Development Co.,Ltd.
Manufacturer SRN: CN-MF-000045412
UDI-DI: 06975781740022
Basic UDI-DI: 697578174002Q6
Reference: KRS-02
EMDN: Z11069001
EMDN description: BIOIMAGING PROCESSORS
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors View details

Vein Finder

HV-500

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Qingdao Hiprove Medical Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000024223
UDI-DI: 06970353803051
Basic UDI-DI: 697035380304478
Reference: HV-500
EMDN: Z11069099
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 16.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Nexxis OR

Class IMDR 2017/745On the marketActive device

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334000780
Basic UDI-DI: 5415334_NexxisOR_P4
Reference: K9303076A
EMDN: Z11069099
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 09:59

Manufacturer products View details

Blackford Accept Reject Tool

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Blackford Analysis Limited
Manufacturer SRN: UK-MF-000044937
UDI-DI: 05060570830334
Basic UDI-DI: 50605VIEWERSMK
Reference: BART001
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Norway
Authorised representative: Advena Limited
Last updated: 16.07.2026 09:49

Manufacturer products Authorised representative products Authorised representative actors View details

DR-ID 900CL

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410316872
Basic UDI-DI: 454741010100000000000463Q
Reference: 04547410316872
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

Buzz O.R. Compute

Class IMDR 2017/745On the marketActive device

Manufacturer: Brainlab SE
Manufacturer SRN: DE-MF-000006183
UDI-DI: 04056481147099
Basic UDI-DI: 4056481O.R.SuiteF6
Reference: 17922
EMDN: Z11069080
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:33

Manufacturer products View details

Intellispace CC & Anesthesia

IntelliSpace CC & Anesthesia

Class IIbMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838113763
Basic UDI-DI: 0884838BM521ST
Reference: 866148
EMDN: Z11069001
EMDN description: BIOIMAGING PROCESSORS
First on market country: Bulgaria
Authorised representative: -
Last updated: 16.07.2026 07:23

Manufacturer products View details

Image Management

15.X

Class IIbMDR 2017/745On the market

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-PR-000001565
UDI-DI: 00884838107557
Basic UDI-DI: 0884838BM832TF
Reference: 839060
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 07:22

Manufacturer products View details

IntelliBridge EC40/80

IntelliBridge Hub

Class IMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: Philips Medical Systems
Manufacturer SRN: US-MF-000002321
UDI-DI: 00884838090811
Basic UDI-DI: 0884838BM651T9
Reference: 865056
EMDN: Z11069001
EMDN description: BIOIMAGING PROCESSORS
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

AV Cardiovascular Suite

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838129924
Basic UDI-DI: 0884838BM1637MW
Reference: 989780000049
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:13

Manufacturer products View details

AV Viewer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838129917
Basic UDI-DI: 0884838BM1871N8
Reference: 989780000042
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:13

Manufacturer products View details

Radiology Operations Command Center Console

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838127746
Basic UDI-DI: 0884838BM1768NE
Reference: 808007
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:13

Manufacturer products View details

CT ASPECT Scoring

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838121584
Basic UDI-DI: 0884838BM1050LQ
Reference: 881093
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:13

Manufacturer products View details

NM Suite

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838121577
Basic UDI-DI: 0884838BM1027LV
Reference: 881090
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:13

Manufacturer products View details

Advanced Visualization Workspace

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medical Systems Nederland B.V.
Manufacturer SRN: NL-MF-000001489
UDI-DI: 00884838121553
Basic UDI-DI: 0884838BM1052LU
Reference: 881120
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:13

Manufacturer products View details