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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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04.08.2026 14:01

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No

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673012007
Basic UDI-DI: B-08431673012007
Reference: 1001200
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:15

Manufacturer products View details

No

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673010201
Basic UDI-DI: B-08431673010201
Reference: 1001020
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:15

Manufacturer products View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 (COVID-19) Antigen Rapid Test

SARS-CoV-2 (COVID-19) Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 07350123504705
Basic UDI-DI: B-07350123504705
Reference: ICOV-803H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

X100HT With Full Field Peripheral Blood Smear (PBS) Application

X100HT With Full Field Peripheral Blood Smear (PBS) Application

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Scopio Labs Ltd.
Manufacturer SRN: IL-MF-000025129
UDI-DI: 07290018417140
Basic UDI-DI: B-07290018417140
Reference: SC-SYS-00002
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 02:59

Manufacturer products Authorised representative products Authorised representative actors View details

X100 With Full Field Peripheral Blood Smear (PBS) Application

X100 With Full Field Peripheral Blood Smear (PBS) Application

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Scopio Labs Ltd.
Manufacturer SRN: IL-MF-000025129
UDI-DI: 07290018417133
Basic UDI-DI: B-07290018417133
Reference: SC-SYS-00001
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 02:59

Manufacturer products Authorised representative products Authorised representative actors View details

10T/BOX

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Runmei Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000017635
UDI-DI: 06979845480022
Basic UDI-DI: B-06979845480022
Reference: RM-R03-014-1.0
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.08.2026 02:59

Manufacturer products Authorised representative products Authorised representative actors View details

Lipids and Glucose Panel

10 tests/kit

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000044146
UDI-DI: 06978189071651
Basic UDI-DI: B-06978189071651
Reference: 10tests/kit
EMDN: W01010402
EMDN description: MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 02:25

Manufacturer products Authorised representative products Authorised representative actors View details

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078457
Basic UDI-DI: B-06978139078457
Reference: ST2 (eCLIA)
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:25

Manufacturer products Authorised representative products Authorised representative actors View details

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078440
Basic UDI-DI: B-06978139078440
Reference: 0320514801
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078433
Basic UDI-DI: B-06978139078433
Reference: 0320514804
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078426
Basic UDI-DI: B-06978139078426
Reference: 0320514803
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075746
Basic UDI-DI: B-06978139075746
Reference: 0320514903
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details