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

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372 device results listed.

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08012992500545

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500545
Basic UDI-DI: B-08012992500545
Reference: 50054
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500538

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500538
Basic UDI-DI: B-08012992500538
Reference: 50053
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500521

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500521
Basic UDI-DI: B-08012992500521
Reference: 50052
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

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03610522158263

AEA IgG POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 03610522158263
Basic UDI-DI: B-03610522158263
Reference: 12012273
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 05.07.2026 17:01

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03610522158256

IgG FITC/EVANS (M) hs

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 03610522158256
Basic UDI-DI: B-03610522158256
Reference: 12012272
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 05.07.2026 17:01

Manufacturer products View details

08435287141016

iPro [IMMUNOFLUORESCENCE PROCESSOR]

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287141016
Basic UDI-DI: 8435287191iPRO000000V3
Reference: 84101
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:47

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08435287115246

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

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08435287112955

BIOSYSTEMS ARA

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287112955
Basic UDI-DI: 8435287191ARA00000004N
Reference: 84500
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:47

Manufacturer products View details

08435287112948

BIOSYSTEMS MIRA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287112948
Basic UDI-DI: 8435287191MIRA000000TN
Reference: 84400
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:47

Manufacturer products View details

08435287111989

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

08435287111668

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

08435287109986

[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

08435287108835

STOOL COLLECTION TUBE

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108835
Basic UDI-DI: 8435287121STLCOLTUBE47
Reference: 31327
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details

08435287108477

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

08435287108446

[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

08435287108101

[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

08435287106572

ACID WASHING SOLUTION

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287106572
Basic UDI-DI: 8435287190ACIDWASHSoEK
Reference: AC17201
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

08435287106138

CONCENTRATED WASHING SOLUTION

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287106138
Basic UDI-DI: 8435287190CONCWASHSoTF
Reference: AC16434
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

08435287104158

WASHING SOLUTION

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287104158
Basic UDI-DI: 8435287190WASHINGSo05P
Reference: AC10415
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

08435287101317

[AUTOANALYZER] BA400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287101317
Basic UDI-DI: 8435287191BA40000000J5
Reference: 83400
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 13:46

Manufacturer products View details