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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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187 device results listed.

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NOVA View® Automated Fluorescence Microscope

NV2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950621614
Basic UDI-DI: 84269506216147E
Reference: NV2000
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite® IFA Yo (PCA-1) Positive Control

NOVA Lite® IFA Yo (PCA-1) Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001045
Basic UDI-DI: 84269505942609N
Reference: 704009
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:10

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite® IFA Pancreatic Islet Cell Positive Control

NOVA Lite® IFA Pancreatic Islet Cell Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001038
Basic UDI-DI: 842695059403195
Reference: 704005
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:10

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite® IFA Hu (ANNA-1) Positive Control

NOVA Lite® IFA Hu (ANNA-1) Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001021
Basic UDI-DI: 8426950594284A4
Reference: 704073
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:10

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash PR3 Calibrators

QUANTA Flash PR3 Calibrators

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950554578
Basic UDI-DI: 84269505545789C
Reference: 701136
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash PR3 Controls

QUANTA Flash PR3 Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950554554
Basic UDI-DI: 84269505545548W
Reference: 701137
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash PR3 Reagents

QUANTA Flash PR3 Reagents

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950544258
Basic UDI-DI: 84269505442588C
Reference: 701138
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details