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EUDAMED Device Search

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AESKULISA® GAD65 SL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504928
Basic UDI-DI: B-04250289504928
Reference: 3606
EMDN: W0102060105
EMDN description: GAD II ANTIBODIES AND OTHER ICA
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

AESKULISA® IA2 SL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504911
Basic UDI-DI: B-04250289504911
Reference: 3605
EMDN: W0102060108
EMDN description: ISLET CELL AB
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

AESKULISA® 25OH Vitamin D

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504652
Basic UDI-DI: B-04250289504652
Reference: 3810
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

AESKULISA® Insulin

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289501613
Basic UDI-DI: B-04250289501613
Reference: 3601
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

D-CPC-R302AR

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CPC-R302AR
Basic UDI-DI: B-CPC-R302AR
Reference: CPC-R302
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™

VMPO09

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250179
Basic UDI-DI: 868354825VMPO09EPP9
Reference: VMPO09EP
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 01:09

Manufacturer products View details

RapidFor™

VMD47

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030837
Basic UDI-DI: 868334794VMD47BP3T
Reference: VMD47FC01LA
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 00:51

Manufacturer products View details

RapidFor™

VMD47

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941537
Basic UDI-DI: 868334794VMD47BP3T
Reference: VMD47BP
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 00:51

Manufacturer products View details

RapidFor™

VMPO26

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250377
Basic UDI-DI: 868354825VMPO26EPP8
Reference: VMPO26EP
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 00:43

Manufacturer products View details

iGFBP-1 Rapid Test Cassette

iGFBP-1 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598226346
Basic UDI-DI: B-06942598226346
Reference: FIG-502
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™

VMPO55

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250933
Basic UDI-DI: 868354825VMPO55EPPQ
Reference: VMPO55EP
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 23:44

Manufacturer products View details

RapidFor™

VMD120SC

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030578
Basic UDI-DI: 868459503VMD120SC8W
Reference: VMD120SC
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 23:07

Manufacturer products View details

PTH Intact AccuLite CLIA Kit - 192 wells

9075-300A