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

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iTrace

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Tracey Technologies
Manufacturer SRN: US-MF-000027372
UDI-DI: 00860479001706
Basic UDI-DI: 08604790017Z2000NN
Reference: Z2000
EMDN: V030203
EMDN description: OPHTHALMOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

00860475000376

Deterioration Index

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Epic Systems Corporation
Manufacturer SRN: US-MF-000002900
UDI-DI: 00860475000376
Basic UDI-DI: 08604750003DIXH
Reference: None
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: Epic Den Bosch B.V.
Last updated: 16.07.2026 06:59

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Provizio SEM Scanner S

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Bruin Biometrics, LLC
Manufacturer SRN: US-MF-000028418
UDI-DI: 00860740002647
Basic UDI-DI: 0860740002647TN
Reference: 02647
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:59

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Provizio SEM Scanner S

Provizio SEM Scanner S Single-Use Sensor

Class IMDR 2017/745On the marketActive deviceMeasuring functionSingle use

Manufacturer: Bruin Biometrics, LLC
Manufacturer SRN: US-MF-000028418
UDI-DI: 00860740002630
Basic UDI-DI: 08607400026026302B
Reference: 02630
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:59

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00860475000369

Early Detection of Sepsis Model

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Epic Systems Corporation
Manufacturer SRN: US-MF-000002900
UDI-DI: 00860475000369
Basic UDI-DI: 08604750003EDSR3
Reference: None
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: Epic Den Bosch B.V.
Last updated: 16.07.2026 06:59

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00860475000352

Risk of Unplanned Readmission Model

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Epic Systems Corporation
Manufacturer SRN: US-MF-000002900
UDI-DI: 00860475000352
Basic UDI-DI: 08604750003URZN
Reference: None
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Netherlands
Authorised representative: Epic Den Bosch B.V.
Last updated: 16.07.2026 06:59

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00860396001971

NIO Laser Imaging System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testing

Manufacturer: Invenio Imaging Inc.
Manufacturer SRN: US-MF-000047250
UDI-DI: 00860396001971
Basic UDI-DI: 08603960019001LV
Reference: PRT 03-2082
EMDN: W0202050302
EMDN description: LASER SCANNING MICROSCOPES
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:59

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NIO Specimen Receptacle

16MM

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingSingle use

Manufacturer: Invenio Imaging Inc.
Manufacturer SRN: US-MF-000047250
UDI-DI: 00860396001926
Basic UDI-DI: 08603960019002LX
Reference: PRT 01-0224
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:59

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Combat Application Tourniquet

Gen7

Class IMDR 2017/745On the marketSingle use

Manufacturer: C-A-T Resources, LLC
Manufacturer SRN: US-MF-000017612
UDI-DI: 00860362002407
Basic UDI-DI: 08603620024CR00770XQX
Reference: 00860362002407
EMDN: C90010301
EMDN description: HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)
First on market country: Austria
Authorised representative: mdi Europa GmbH
Last updated: 16.07.2026 06:59

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ZENO ELECTRONIC WALKWAY

PLATINUM

Class IMDR 2017/745On the marketActive deviceContains latexDirect marking

Manufacturer: ZENOMETRICS LLC
Manufacturer SRN: US-MF-000016122
UDI-DI: 00860252000704
Basic UDI-DI: 08602520007ZENO_WALKWAYZR
Reference: Z418-220 ALL SIZES
EMDN: V0399
EMDN description: MEASUREMENT DEVICES - OTHER
First on market country: France
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details

Trackmaster

Trackmaster Treadmill

Class IMDR 2017/745On the marketActive device

Manufacturer: Full Vision, Inc
Manufacturer SRN: US-MF-000002038
UDI-DI: 00860176000606
Basic UDI-DI: 08601760006FVITMR4
Reference: 317-07926
EMDN: Z129006
EMDN description: TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:58

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HUMAC NORM

502140

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Computer Sports Medicine, Inc.
Manufacturer SRN: US-MF-000037948
UDI-DI: 00860139000308
Basic UDI-DI: 08601390003502140VG
Reference: 502140
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details

Medit Orthodontic Suite

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Progressive Orthodontics USA
Manufacturer SRN: US-MF-000045054
UDI-DI: 00860016086920
Basic UDI-DI: 0860016086920TH
Reference: 2.3.0
EMDN: Z12119092
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: Progressive Dental Supplies SL
Last updated: 16.07.2026 06:58

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FIX&PERM® Cell Fixation and Permeabilization kit

FIX&PERM®

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Vector Laboratories, Inc.
Manufacturer SRN: US-MF-000057003
UDI-DI: 00860015684509
Basic UDI-DI: 08600156845FIXPERMCEIVDRQ
Reference: GAS-002-CE/IVD
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:58

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OptraSCAN Digital Pathology System

ImagePath

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: OptraSCAN Inc.
Manufacturer SRN: US-MF-000051112
UDI-DI: 00860015108166
Basic UDI-DI: 08600151081IMAGEPATHV6
Reference: OSDPS-IMAGEPATH
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Türkiye
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details

OptraSCAN Digital Pathology System

OS-Ultra System, OS-Lite System, OS-SiX System, OS-FS System, OS-Fli System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: OptraSCAN Inc.
Manufacturer SRN: US-MF-000051112
UDI-DI: 00860015108104
Basic UDI-DI: 08600151081OSDIGIPATHSY3Y
Reference: OSDPS-OS-ULTRA-SYSTEM
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Türkiye
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details

Hemophilia Bleeding Disorders

Microhealth Bleeding Disorders

Class IMDR 2017/745On the marketActive device

Manufacturer: Microhealth Inc
Manufacturer SRN: US-MF-000050690
UDI-DI: 00860015078704
Basic UDI-DI: 08600150787BD01ET
Reference: pdproj-01
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: Microhealth España SL
Last updated: 16.07.2026 06:58

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

eRAD Viewer

9.y.z

Class IIaMDR 2017/745On the marketActive device

Manufacturer: eRAD, Inc.
Manufacturer SRN: US-MF-000018514
UDI-DI: 00860014963742
Basic UDI-DI: 08600149637ViewerXR
Reference: 9.y.z
EMDN: Z119082
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: Képdoktor Számítástechnikai, Kereskedelmi és Fejlesztő Kft.
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details

Kinesiology tape

KT-MIX

Class IMDR 2017/745On the marketSingle use

Manufacturer: Ceeport inc.
Manufacturer SRN: US-MF-000053401
UDI-DI: 00860014862366
Basic UDI-DI: 08600148623KT-MIXVV
Reference: KT-2HL-C
EMDN: M030403
EMDN description: FUNCTIONAL BANDAGES WITH ANELASTIC TAPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details