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06977207040037

iOrtho Platform

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shanghai EA Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000040940
UDI-DI: 06977207040037
Basic UDI-DI: 697720704SOFTWARE002V8
Reference: iOrtho Platform
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

06977207040020

iOrtho

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shanghai EA Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000040940
UDI-DI: 06977207040020
Basic UDI-DI: 697720704SOFTWARE001V6
Reference: iOrtho
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

4K 3D Endoscopic Fluorescence Camera System

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Shinevia (Shandong) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000049465
UDI-DI: 16976982090913
Basic UDI-DI: 6976982093DEFCSN3
Reference: HORUS CAM-4030
EMDN: Z11069080
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE
First on market country: Spain
Authorised representative: Everbiz GmbH
Last updated: 02.07.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

4K endoscopic fluorescence camera system

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Shinevia (Shandong) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000049465
UDI-DI: 16976982090876
Basic UDI-DI: 697698209EFCSU9
Reference: HORUS CAM-4100A
EMDN: Z11069080
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE
First on market country: France
Authorised representative: Everbiz GmbH
Last updated: 02.07.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Camera System

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Shinevia (Shandong) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000049465
UDI-DI: 16976982090814
Basic UDI-DI: 697698209FCSY5
Reference: ARGOS NIR-300PT
EMDN: Z11069080
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE
First on market country: Italy
Authorised representative: Everbiz GmbH
Last updated: 02.07.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

Parathyroid Imaging System

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Shinevia (Shandong) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000049465
UDI-DI: 16976982090807
Basic UDI-DI: 697698209PIS2C
Reference: ARGOS-200PT
EMDN: Z11069080
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE
First on market country: Greece
Authorised representative: Everbiz GmbH
Last updated: 02.07.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

06975775330154

SenseCare-TCT

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SenseCare Smart Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000016662
UDI-DI: 06975775330154
Basic UDI-DI: 697577533015PX
Reference: SenseCare-TCT
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

06973065280196

SenseCare-Path manage

Class IMDR 2017/745On the marketActive device

Manufacturer: SenseCare Smart Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000016662
UDI-DI: 06973065280196
Basic UDI-DI: 697306528019JT
Reference: /
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 13:31

Manufacturer products Authorised representative products Authorised representative actors View details

06973065280219

SenseCare-Path process

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SenseCare Smart Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000016662
UDI-DI: 06973065280219
Basic UDI-DI: 697306528021JE
Reference: /
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 13:31

Manufacturer products Authorised representative products Authorised representative actors View details

eUnity

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Mach7 Technologies Canada Inc
Manufacturer SRN: CA-MF-000037258
UDI-DI: 00628914000017
Basic UDI-DI: 628914EU-X.x9M
Reference: eUnity v.7.7+
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Reveal 35C

101

Class IIaMDR 2017/745On the marketActive device

Manufacturer: KA Imaging Inc.
Manufacturer SRN: CA-MF-000030642
UDI-DI: 00628011941015
Basic UDI-DI: 628011941FPD0100Z7
Reference: Reveal 35C
EMDN: Z11069099
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Qualrep Services B.V.
Last updated: 02.07.2026 08:30

Manufacturer products Authorised representative products Authorised representative actors View details

Faxitron Core Specimen Radiography System

Faxitron Radiography System

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic Inc.
Manufacturer SRN: US-MF-000003332
UDI-DI: 15420045514218
Basic UDI-DI: 54200455FAXITRONCABXRAYBU
Reference: COREVISION5X10
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trident HD Specimen Radiography System

Trident® HD Specimen Radiography System

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic Inc.
Manufacturer SRN: US-MF-000003332
UDI-DI: 15420045512214
Basic UDI-DI: 54200455TRIDENTHDDN
Reference: TRI-00002
EMDN: Z11069005
EMDN description: DIAGNOSTIC IMAGING WORKSTATIONS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

DS Core Resto

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352350042
Basic UDI-DI: 426235235-S3817-000-YC
Reference: 04262352350042
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

DI Scan

Class IMDR 2017/745No longer on the marketActive device

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352359243
Basic UDI-DI: 426235235-S3806-001-XH
Reference: 04262352359243
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

DS Core Detect

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352357935
Basic UDI-DI: 426235235-S3851-000-Y2
Reference: 04262352357935
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

DS Core CBCT Anatomy

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352350080
Basic UDI-DI: 426235235-S3816-000-XX
Reference: 04262352350080
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

DI Scan

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352350035
Basic UDI-DI: 426235235-S3806-002-XL
Reference: 04262352350035
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

DS Core Diagnosis

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352350028
Basic UDI-DI: 426235235-S3809-000-YM
Reference: 04262352350028
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

DI Scan

Class IMDR 2017/745No longer on the market

Manufacturer: Zetta25 AG
Manufacturer SRN: CH-MF-000022840
UDI-DI: 04262352350011
Basic UDI-DI: 426235235-S3806-000-XE
Reference: 04262352350011
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: DS REP B.V.
Last updated: 01.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details