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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 18:01

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Pic Diabetes Management

99DMS30

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724817
Basic UDI-DI: 88001117IAAA02PA15LL
Reference: 99DMS30
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoNavii® App

G-APP-01

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724800
Basic UDI-DI: 88001117IAAA01PA16LB
Reference: 01APP10
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Exdia PT10

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Precision Biosensor Inc.
Manufacturer SRN: KR-MF-000034861
UDI-DI: 08800026300229
Basic UDI-DI: 88000263PDPT10FQ
Reference: PD-PT10
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 03.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

OX7000-01

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: BIOLAN MICROBIOSENSORES S.L.
Manufacturer SRN: ES-MF-000001992
UDI-DI: 08437022705125
Basic UDI-DI: 8437022705XYLDEV01BR
Reference: OX7000-01
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:11

Manufacturer products View details

CLIMA PLUS

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RAL TECNICA PARA EL LABORATORIO, S.A.
Manufacturer SRN: ES-MF-000000306
UDI-DI: 08435491999915
Basic UDI-DI: 84354919CLIMAPLUS0159
Reference: RA133000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:08

Manufacturer products View details

CLIMA MC15

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RAL TECNICA PARA EL LABORATORIO, S.A.
Manufacturer SRN: ES-MF-000000306
UDI-DI: 08435491999908
Basic UDI-DI: 84354919CLIMAMC1501LN
Reference: RA115000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:07

Manufacturer products View details

STARDUST MC 15

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RAL TECNICA PARA EL LABORATORIO, S.A.
Manufacturer SRN: ES-MF-000000306
UDI-DI: 08435491999892
Basic UDI-DI: 84354919STDUSTMC1501WJ
Reference: RA116000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:07

Manufacturer products View details

CLIMA JR

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RAL TECNICA PARA EL LABORATORIO, S.A.
Manufacturer SRN: ES-MF-000000306
UDI-DI: 08435491999854
Basic UDI-DI: 84354919CLIMAJR01L3
Reference: RA135000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:07

Manufacturer products View details

LIDA 800 Automatic Clinical Chemistry Analyzer

LIDA 800 Automatic Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393804
Basic UDI-DI: 843528739380JA
Reference: 1805800
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

LIDA 300 Automatic Clinical Chemistry Analyzer

LIDA-300 Automatic Clinical Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393606
Basic UDI-DI: 843528739360J4
Reference: 1805000
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

LIDA 500 Automatic Clinical Chemistry Analyzer

LIDA-500 Automatic Clinical Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393408
Basic UDI-DI: 843528739340HW
Reference: 1805500
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

KROMA Plus Automatic Clinical Chemistry Analyzer

KROMA PLUS Automatic Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393200
Basic UDI-DI: 843528739320HQ
Reference: 1800100
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

KROMA Automatic Clinical Chemistry Analyzer

KROMA Automatic Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393002
Basic UDI-DI: 843528739300HJ
Reference: 1800050
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

CONCENTRATED SYSTEM LIQUID

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287115246
Basic UDI-DI: 8435287190CONCSYSTLIZ8
Reference: BO11524
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:47

Manufacturer products View details

BTS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287111989
Basic UDI-DI: 8435287191BTS0000000HP
Reference: 83000
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details

HIGH ALKALINE WASHING SOLUTION

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287111668
Basic UDI-DI: 8435287190HALKWASHSoQY
Reference: AC16435
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details

[RANDOM ACCESS ANALYZER] A15

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287109986
Basic UDI-DI: 8435287191A15000000072
Reference: 83105C
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details

ALKALINE WASHING SOLUTION

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108477
Basic UDI-DI: 8435287190ALKAWASHSoLM
Reference: AC17205
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details

[AUTOANALYZER] BA200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108446
Basic UDI-DI: 8435287191BA20000000GX
Reference: 83200
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details

[RANDOM ACCESS ANALYZER] A25

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108101
Basic UDI-DI: 8435287191A2500000007R
Reference: 83101
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details