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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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181 device results listed.

Page 9 / 10

Aptiva Celiac Disease IgA Calibrators

-

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040570
Basic UDI-DI: 84307930405703N
Reference: 724121
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:25

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva Celiac Disease IgA Reagent

-

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040532
Basic UDI-DI: 84307930405323E
Reference: 724120
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:25

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva Celiac Disease IgG Controls

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IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040525
Basic UDI-DI: 84307930405253H
Reference: 724102
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:25

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva Celiac Disease IgG Calibrators

-

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040518
Basic UDI-DI: 84307930405183L
Reference: 724101
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:25

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva Celiac Disease IgG Reagent

-

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040471
Basic UDI-DI: 84307930404713K
Reference: 724100
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:25

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva Instrument System Cuvettes

Instrument System Cuvettes

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126000741
Basic UDI-DI: 84307930458034R
Reference: AC1005
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Multi-Analyte Instrument

AP5000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426951307227
Basic UDI-DI: 84269513072276Z
Reference: AP5000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:14

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 IFA

VS3002

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865131
Basic UDI-DI: 84269508651319P
Reference: VS3002
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 ELISA/IFA + Incubator

VS3000i

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865100
Basic UDI-DI: 84269508651009C
Reference: VS3000i
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 ELISA/IFA

VS3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865094
Basic UDI-DI: 8426950865094AA
Reference: VS3000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA View® AUTOLoader

ADLR1000

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950643708
Basic UDI-DI: 84269506437088U
Reference: ADLR1000
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

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: 08426950627692
Basic UDI-DI: 84269506276929C
Reference: 701135
EMDN: W0102100403
EMDN description: PR3 ANCA
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 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

Aptiva System Cleaning Solution Kit

-

IVD Class ANot specifiedOn the market

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126000871
Basic UDI-DI: 0195126000871QG
Reference: AC1003
EMDN: -
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 29.06.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details