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EUDAMED Device Search

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

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747 device results listed.

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03661540301506

OA-100

IVD generalIVDDOn the marketKit

Manufacturer: ELITechGroup Inc.
Manufacturer SRN: US-MF-000006942
UDI-DI: 03661540301506
Basic UDI-DI: B-03661540301506
Reference: OA-100
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

03661540301490

OA-029

IVD generalIVDDOn the marketKit

Manufacturer: ELITechGroup Inc.
Manufacturer SRN: US-MF-000006942
UDI-DI: 03661540301490
Basic UDI-DI: B-03661540301490
Reference: OA-029
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

03661540301483

OA-010

IVD generalIVDDOn the marketKit

Manufacturer: ELITechGroup Inc.
Manufacturer SRN: US-MF-000006942
UDI-DI: 03661540301483
Basic UDI-DI: B-03661540301483
Reference: OA-010
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ABX Pentra Micro ALB 2 Cal

1300032565

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008232
Basic UDI-DI: B-03610230008232
Reference: 1300032565
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 17:00

Manufacturer products View details

ABX Pentra SP Cal

A11A01927

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005699
Basic UDI-DI: B-03610230005699
Reference: A11A01927
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 17:00

Manufacturer products View details

ABX Pentra Reference 280mL

A11A01901

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005613
Basic UDI-DI: B-03610230005613
Reference: A11A01901
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra TPU Cal

A11A01898

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005590
Basic UDI-DI: B-03610230005590
Reference: A11A01898
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra Reference

A11A01719

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005446
Basic UDI-DI: B-03610230005446
Reference: A11A01719
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra Standard 2

A11A01718

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005439
Basic UDI-DI: B-03610230005439
Reference: A11A01718
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra Standard 1

A11A01717

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005422
Basic UDI-DI: B-03610230005422
Reference: A11A01717
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra Multical

A11A01652

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005125
Basic UDI-DI: B-03610230005125
Reference: A11A01652
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra CO2 Cal

A11A01648

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005101
Basic UDI-DI: B-03610230005101
Reference: A11A01648
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra RF Cal

A11A01618

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004845
Basic UDI-DI: B-03610230004845
Reference: A11A01618
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

STANDARD™ M10 Calibration Kit

M10-CAL-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111711350
Basic UDI-DI: 88001117IPAA01MA02W4
Reference: M10-CAL-01/11CAL10H
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ F Calibration Kit

FCAL-10

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111711213
Basic UDI-DI: 88001117IPAA01FA29V7
Reference: 10CAL10
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

CFΔ Collection System

CTL3

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000103
Basic UDI-DI: 86992260CTL3(130)YZ
Reference: CTL3
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

CFΔ Collection System

CAL90

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000073
Basic UDI-DI: 86992260CAL90RQ
Reference: CAL90
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

CFΔ Collection System

CTL2

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000097
Basic UDI-DI: 86992260CTL2(70)UP
Reference: CTL2
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

CFΔ Collection System

CTL1

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000080
Basic UDI-DI: 86992260CTL1(40)TV
Reference: CTL1
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

Aptiva® Optical Calibrator Kit

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793041126
Basic UDI-DI: 843079304112636
Reference: AC1001
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details