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

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17.07.2026 13:39

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372 device results listed.

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08435287108996

D-DIMER STANDARD

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108996
Basic UDI-DI: B-08435287108996
Reference: 18077
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:43

Manufacturer products View details

08435287108989

D-DIMER CONTROLS I / II

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108989
Basic UDI-DI: B-08435287108989
Reference: 18078
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108972

D-DIMER

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108972
Basic UDI-DI: B-08435287108972
Reference: 21519
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108965

GLUCOSE-6-PHOSPHATE DEHYDROGENASE

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108965
Basic UDI-DI: B-08435287108965
Reference: 21603
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108842

FECAL OCCULT BLOOD (FOB) STANDARD

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108842
Basic UDI-DI: B-08435287108842
Reference: 31326
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108798

IgG FITC/EVANS (M) hs

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108798
Basic UDI-DI: B-08435287108798
Reference: 44914
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108781

IgG FITC/EVANS (M) hs

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108781
Basic UDI-DI: B-08435287108781
Reference: 44915
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108774

FITC/EVANS (R)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108774
Basic UDI-DI: B-08435287108774
Reference: 44916
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108699

FIBRINOGEN CLAUSS

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108699
Basic UDI-DI: B-08435287108699
Reference: 61020
EMDN: W0103020299
EMDN description: COAGULATION FACTORS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108538

BILIRUBIN (TOTAL) [DPD]

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108538
Basic UDI-DI: B-08435287108538
Reference: 12506
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108415

ADENOSINE DEAMINASE (ADA)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108415
Basic UDI-DI: B-08435287108415
Reference: 23754
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108354

HOMOCYSTEINE

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108354
Basic UDI-DI: B-08435287108354
Reference: 23737
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108330

BILIRUBIN (TOTAL) [DPD]

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108330
Basic UDI-DI: B-08435287108330
Reference: 23506
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108316

BILIRUBIN (TOTAL) [DPD]

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108316
Basic UDI-DI: B-08435287108316
Reference: 21506
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108286

beta2-MICROGLOBULIN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108286
Basic UDI-DI: B-08435287108286
Reference: 23925
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108279

FIBRINOGEN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108279
Basic UDI-DI: B-08435287108279
Reference: 23804
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108019

P-ANCA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108019
Basic UDI-DI: B-08435287108019
Reference: 44913
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287108002

C-ANCA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108002
Basic UDI-DI: B-08435287108002
Reference: 44912
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287106602

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287106602
Basic UDI-DI: B-08435287106602
Reference: 44911
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287106503

ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287106503
Basic UDI-DI: B-08435287106503
Reference: 61009
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details