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QLAB 13.0

QLAB Advanced Quantification Software

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838091672
Basic UDI-DI: 0884838BM434SX
Reference: 989605496481
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
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

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

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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

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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

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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

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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

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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

TOMTEC-ARENA

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838121423
Basic UDI-DI: 0884838BM1161M2
Reference: 795103
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:13

Manufacturer products Authorised representative products Authorised representative actors View details

Philips FetView

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Philips Ultrasound LLC
Manufacturer SRN: US-MF-000002237
UDI-DI: 00884838115958
Basic UDI-DI: 0884838BM1051LS
Reference: 795268
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:12

Manufacturer products Authorised representative products Authorised representative actors View details

Examvue CR Dental

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DIGIRAY Corp.
Manufacturer SRN: KR-MF-000024601
UDI-DI: 08809466041211
Basic UDI-DI: 08809466041213U
Reference: Examvue CR Dental
EMDN: Z11060201
EMDN description: SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 07:06

Manufacturer products Authorised representative products Authorised representative actors View details

FireCR Dental

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DIGIRAY Corp.
Manufacturer SRN: KR-MF-000024601
UDI-DI: 08809466040214
Basic UDI-DI: 08809466040213P
Reference: FireCR Dental
EMDN: Z11060201
EMDN description: SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 07:06

Manufacturer products Authorised representative products Authorised representative actors View details

eRAD PACS

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: eRAD, Inc.
Manufacturer SRN: US-MF-000018514
UDI-DI: 00866994000224
Basic UDI-DI: 08669940002246A
Reference: eRAD PACS
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Hungary
Authorised representative: Képdoktor Számítástechnikai, Kereskedelmi és Fejlesztő Kft.
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

00861625000437

Reveal Family

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Ceevra, Inc.
Manufacturer SRN: US-MF-000042119
UDI-DI: 00861625000437
Basic UDI-DI: 08616250004reveal3A
Reference: Reveal 3
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Suite

1.y.z

Class IMDR 2017/745On the marketActive device

Manufacturer: DeepHealth, Inc.
Manufacturer SRN: US-MF-000051664
UDI-DI: 00860014963759
Basic UDI-DI: 08600149637DxSVW
Reference: V.1.y.z
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Austria
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details

00860007211300

CHLOE

Class IMDR 2017/745On the market

Manufacturer: Fairtility Ltd.
Manufacturer SRN: IL-MF-000033943
UDI-DI: 00860007211300
Basic UDI-DI: 08600072113CHLOEET
Reference: CHLOE EQ™
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

qER-NCCT

qSuite

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Qure.ai Technologies Private Limited
Manufacturer SRN: IN-MF-000018096
UDI-DI: 00860005118120
Basic UDI-DI: 08600051181qER-NCCTTL
Reference: v1.0
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: Advena Limited
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Synapse CV

Class IIaMDR 2017/745On the market

Manufacturer: FUJIFILM Healthcare Americas Corporation
Manufacturer SRN: US-MF-000009244
UDI-DI: 00854904006015
Basic UDI-DI: 0854904006HCUSCV6Z
Reference: Synapse CV
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

Synapse PACS

Class IIaMDR 2017/745On the market

Manufacturer: FUJIFILM Healthcare Americas Corporation
Manufacturer SRN: US-MF-000009244
UDI-DI: 00854904006008
Basic UDI-DI: 0854904006HCUSPACSWY
Reference: Synapse PACS
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina PC cfg

iTero Lumina – PC cfg

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-PR-000047276
UDI-DI: 00816063023203
Basic UDI-DI: 081606302LMN22SYSEL
Reference: 223100
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 04:20

Manufacturer products View details