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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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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

iTero Lumina - PC cfg intraoral scanning unit

iTero Lumina PC cfg Intraoral Scanning Unit

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063023050
Basic UDI-DI: 081606302LMNSCNUEV
Reference: 223102
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Lumina Cart Configuration

iTero Lumina System

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063021414
Basic UDI-DI: 081606302LMNSYS9L
Reference: 213782
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 5D

iTero Element 5D Family

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020493
Basic UDI-DI: 081606302DISBH
Reference: 205929
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

iTero Element 2

iTero Element 2 family

Class IMDR 2017/745On the marketActive device

Manufacturer: Align Technology Ltd.
Manufacturer SRN: IL-MF-000000745
UDI-DI: 00816063020288
Basic UDI-DI: 081606302ELEMENT6L
Reference: 202965
EMDN: Z110601
EMDN description: LASER IMAGING SCANNER
First on market country: Netherlands
Authorised representative: Align Technology B.V.
Last updated: 16.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

Virtua

Virtua Medical Disc Publisher

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Codonics Inc.
Manufacturer SRN: US-MF-000008190
UDI-DI: 00814905020328
Basic UDI-DI: 081490502VRMDP01KK
Reference: Virtua
EMDN: Z11069099
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

Helion

116001

Class IMDR 2017/745On the marketActive device

Manufacturer: Videomed Srl
Manufacturer SRN: IT-MF-000024944
UDI-DI: 00615521031572
Basic UDI-DI: 0615521GMN1160018M
Reference: VR401111-1
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 01:04

Manufacturer products View details

Web, DirectView Software

DirectView PC Software Application

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

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959028630
Basic UDI-DI: 0606959BM132LN
Reference: 1055635
EMDN: Z11069001
EMDN description: BIOIMAGING PROCESSORS
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 00:52

Manufacturer products Authorised representative products Authorised representative actors View details

syngo Dynamics

MDR_05_IIb_FOR AG S3_syngo Dynamics

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151034202
Basic UDI-DI: 0405686902381VS
Reference: 11708404
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

Manufacturer products View details

Syngo Carbon Space

MDR_DnA_IIb_SHS_AG_SAMD_SPACE

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151064551
Basic UDI-DI: 0405686902372VR
Reference: 11926807
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

Manufacturer products View details