EUDAMED Device Search

ARCHITECT Insulin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740169800
Basic UDI-DI: 038074ARK0841N9
Reference: 08K4103
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 14:41

Alinity i Homocysteine

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740153496
Basic UDI-DI: 038074AIP0928LQ
Reference: 09P2820
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 14:41

Alinity i SHBG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740151379
Basic UDI-DI: 038074AIP0938LT
Reference: 09P3801
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 14:41

Alinity i Insulin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740150792
Basic UDI-DI: 038074AIT0475ML
Reference: 04T7501
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 14:41

Alinity i DHEA-S

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740150624
Basic UDI-DI: 038074AIP0937LR
Reference: 09P3701
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 14:41

ARCHITECT Homocysteine

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740001223
Basic UDI-DI: 038074ARL0171MS
Reference: 01L7101
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 14:40

FOB Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414735727
Basic UDI-DI: 695441470234H7
Reference: IF2042
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

mAlb Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414734614
Basic UDI-DI: 695441470209H8
Reference: IF2009
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414729399
Basic UDI-DI: 695441479278KS
Reference: IF2139
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

ARCHITECT C-Peptide

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740155995
Basic UDI-DI: 038074ARL0353N2
Reference: 03L5302
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:02

Alinity i C-Peptide

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740153526
Basic UDI-DI: 038074AIP0936LP
Reference: 09P3610
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:02

Alinity i CYFRA 21-1

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740153991
Basic UDI-DI: 038074AIP0940LE
Reference: 09P4001
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:01

Alinity i Anti-CCP

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740151348
Basic UDI-DI: 038074AIP0927LN
Reference: 09P2701
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 12:01

Alinity i ProGRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740149970
Basic UDI-DI: 038074AIP0932LF
Reference: 09P3201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:01

Alinity i Urine NGAL

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740138233
Basic UDI-DI: 038074LGF0010LB
Reference: 09P2901
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:01

Alinity i HE4

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740131067
Basic UDI-DI: 038074AIP0850LC
Reference: 08P5001
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:01

Alinity i LH

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740121525
Basic UDI-DI: 038074AIP0791LM
Reference: 07P9101
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:01

ARCHITECT CYFRA 21-1

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740004002
Basic UDI-DI: 038074ARP0255PD
Reference: 02P5501
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:01

ARCHITECT LH

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740003913
Basic UDI-DI: 038074ARP0240NY
Reference: 02P4001
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:00