Public EUDAMED Search

EUDAMED Device Search

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

Last updated

18.09.2026 15:50

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Successful

Device

3108040

Actor

47631

Certificate

3283

Active filter:Manufacturer SRN:US-MF-000017851

187 device results listed.

Page 1 / 10

Aptiva® Vasculitis Kits Pack - 3

Aptiva® Vasculitis Kits Pack - 1

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
00195126001076
Basic UDI-DI
0195126001069PU
Reference
722104
EMDN
W0102100403
EMDN description
PR3 ANCA
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
10.08.2026 23:16
IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
00195126001083
Basic UDI-DI
0195126001069PU
Reference
722105
EMDN
W0102100403
EMDN description
PR3 ANCA
First on market country
-
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
10.08.2026 22:46
Aptiva® Vasculitis Kits Pack - 1

Aptiva® Vasculitis Kits Pack - 1

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
00195126001069
Basic UDI-DI
0195126001069PU
Reference
722103
EMDN
W0102100403
EMDN description
PR3 ANCA
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
08.08.2026 06:37
Aptiva® APS IgA Controls

Aptiva® APS IgA Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040846
Basic UDI-DI
843079304084648
Reference
725122
EMDN
W0102152011
EMDN description
CONTROLS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
05.08.2026 16:41
Aptiva® APS IgA Calibrators

Aptiva® APS IgA Calibrators

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040839
Basic UDI-DI
84307930408394B
Reference
725121
EMDN
W0102152211
EMDN description
STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
05.08.2026 16:41
Aptiva® APS IgA Reagent

Aptiva® APS IgA Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040785
Basic UDI-DI
84307930407854D
Reference
725120
EMDN
W0102100503
EMDN description
ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
05.08.2026 16:41
Aptiva

Aptiva® Celiac IgA Disease Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040570
Basic UDI-DI
B-08430793040570
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
05.08.2026 14:50
Aptiva

Aptiva® Celiac IgA Disease Controls

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040587
Basic UDI-DI
B-08430793040587
Reference
724122
EMDN
W0102152011
EMDN description
CONTROLS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 04:15
Aptiva

Aptiva® Celiac IgA Disease Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040532
Basic UDI-DI
B-08430793040532
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
04.08.2026 04:15
Aptiva

Aptiva® Celiac Disease IgG Controls

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040525
Basic UDI-DI
B-08430793040525
Reference
724102
EMDN
W0102152011
EMDN description
CONTROLS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 04:15
Aptiva

Aptiva® Celiac Disease IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040518
Basic UDI-DI
B-08430793040518
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
04.08.2026 04:15
Aptiva

Aptiva® Celiac Disease IgG Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040471
Basic UDI-DI
B-08430793040471
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
04.08.2026 04:15
Aptiva

Aptiva® CTD Essential Controls

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040198
Basic UDI-DI
B-08430793040198
Reference
723102
EMDN
W0102152011
EMDN description
CONTROLS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 04:15
Aptiva

Aptiva® CTD Essential Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040181
Basic UDI-DI
B-08430793040181
Reference
723101
EMDN
W0102152211
EMDN description
STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 04:15
Aptiva

Aptiva® CTD Essential Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040051
Basic UDI-DI
B-08430793040051
Reference
723100
EMDN
W0102100199
EMDN description
AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 04:15
QUANTA Flash

QUANTA Flash® MPO Calibrators

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
D-701131N9
Basic UDI-DI
B-701131N9
Reference
701131
EMDN
W0102152211
EMDN description
STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
17.07.2026 04:28
Aptiva System Cleaning Solution Kit

Aptiva System Cleaning Solution Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
00195126000871
Basic UDI-DI
0195126000871QG
Reference
AC1003
EMDN
W01019001
EMDN description
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
15.07.2026 23:03
QUANTA Flash

QUANTA Flash® Intrinsic Factor Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793039970
Basic UDI-DI
B-08430793039970
Reference
701358
EMDN
W0102109099
EMDN description
AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
07.07.2026 23:30
QUANTA Flash

QUANTA Flash® Intrinsic Factor Controls

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793039963
Basic UDI-DI
B-08430793039963
Reference
701357
EMDN
W0102152011
EMDN description
CONTROLS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
07.07.2026 23:29
QUANTA Flash

QUANTA Flash® Intrinsic Factor Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793039956
Basic UDI-DI
B-08430793039956
Reference
701356
EMDN
W0102152211
EMDN description
STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
07.07.2026 23:29