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

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Alinity

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

Manufacturer products View details

Alinity

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

Manufacturer products View details

Alinity

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

Manufacturer products View details

Alinity

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

Manufacturer products View details

Alinity

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

Manufacturer products View details

Alinity

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

Manufacturer products View details

Alinity

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

Manufacturer products View details

ARCHITECT

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

Manufacturer products View details

ARCHITECT

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

Manufacturer products View details

ARCHITECT

ARCHITECT HE4

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740003975
Basic UDI-DI: 038074ARP0254PB
Reference: 02P5401
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:00

Manufacturer products View details

ARCHITECT

ARCHITECT Anti-CCP

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740002022
Basic UDI-DI: 038074ARP0165PB
Reference: 01P6501
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 12:00

Manufacturer products View details

ARCHITECT

ARCHITECT ProGRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740001971
Basic UDI-DI: 038074ARP0145P5
Reference: 01P4527
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:00

Manufacturer products View details

AMH Control

Analyzer (automatic and non-automatic)

IVD Class BIVDR 2017/746Not intended for EU marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050027
Basic UDI-DI: 697492505000001T4
Reference: BYZKA0103
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 11:30

Manufacturer products Authorised representative products Authorised representative actors View details

NG Precision+

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077401864
Basic UDI-DI: 37010774PRECISIONPL_OTCU8
Reference: NGB-HCG-W21-014
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Sweden
Authorised representative: -
Last updated: 23.09.2026 10:31

Manufacturer products View details

ARCHITECT

ARCHITECT DHEA-S

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740160722
Basic UDI-DI: 038074ARK0827NF
Reference: 08K2702
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:28

Manufacturer products View details

ARCHITECT

ARCHITECT SHBG

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740156053
Basic UDI-DI: 038074ARK0826ND
Reference: 08K2602
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 10:28

Manufacturer products View details

ARCHITECT

ARCHITECT Intact PTH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740156022
Basic UDI-DI: 038074ARK0825NB
Reference: 08K2513
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:28

Manufacturer products View details

ARCHITECT

ARCHITECT Free PSA

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740014643
Basic UDI-DI: 038074ARK0771ND
Reference: 07K7101
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 10:28

Manufacturer products View details

ARCHITECT

Architect 2nd Generation Testosterone

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740003708
Basic UDI-DI: 038074ARP0213NV
Reference: 02P1301
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:28

Manufacturer products View details

NG Precision+

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077402076
Basic UDI-DI: 37010774PRECISIONPL_OTCU8
Reference: NGB-HCG-W21-019
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 10:26

Manufacturer products View details