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

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663 device results listed.

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08435287147056

ANTI-dsDNA ANTIBODIES

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287147056
Basic UDI-DI: B-08435287147056
Reference: 44705
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287145465

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145465
Basic UDI-DI: B-08435287145465
Reference: 44546
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144475

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144475
Basic UDI-DI: B-08435287144475
Reference: 44547
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144093

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144093
Basic UDI-DI: B-08435287144093
Reference: 44509
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144086

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144086
Basic UDI-DI: B-08435287144086
Reference: 44508
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287141085

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287141085
Basic UDI-DI: B-08435287141085
Reference: 44108
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

NOVA Lite

NOVA Lite® DAPI dsDNA Crithidia lucilae

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426951056538
Basic UDI-DI: B-08426951056538
Reference: 708215
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® HMGCR Reagents

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950793182
Basic UDI-DI: B-08426950793182
Reference: 701333
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® Scl-70 Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950724476
Basic UDI-DI: B-08426950724476
Reference: 701328
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® ENA7 Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950627821
Basic UDI-DI: B-08426950627821
Reference: 701255
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® CTD Screen Plus Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle useSterile

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950627791
Basic UDI-DI: B-08426950627791
Reference: 701220
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® dsDNA Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950627760
Basic UDI-DI: B-08426950627760
Reference: 701175
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® dsDNA Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950624646
Basic UDI-DI: B-08426950624646
Reference: 701178
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950621843
Basic UDI-DI: B-08426950621843
Reference: 704320
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® Ro52 Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950596523
Basic UDI-DI: B-08426950596523
Reference: 701263
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® Ro60 Reagents

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950595878
Basic UDI-DI: B-08426950595878
Reference: 701148
EMDN: W0102100112
EMDN description: SS-A
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® SS-B Reagents

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950595786
Basic UDI-DI: B-08426950595786
Reference: 701153
EMDN: W0102100113
EMDN description: SS-B
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® Centromere Reagents

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950595632
Basic UDI-DI: B-08426950595632
Reference: 701198
EMDN: W0102100115
EMDN description: ANTI-CENTROMERE ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® Sm Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950595533
Basic UDI-DI: B-08426950595533
Reference: 701123
EMDN: W0102100111
EMDN description: SM
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® RNP Reagents

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950595151
Basic UDI-DI: B-08426950595151
Reference: 701118
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details