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EUDAMED Device Search

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

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ARCHITECT

ARCHITECT Urine NGAL

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740001858
Basic UDI-DI: 038074LGF0009LS
Reference: 01P3701
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 08:58

Manufacturer products View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

IVD generalNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098942
Basic UDI-DI: B-06970493098942
Reference: XQ-0010-01
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® Hematoxylin; RTU, cartridge containing 250 tests

Tissue-Tek Genie® Ancillary Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001672
Basic UDI-DI: 06152338224J6
Reference: 8830-M250
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 23.09.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

ARCHITECT

ARCHITECT CA 125 II

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740145347
Basic UDI-DI: 038074ARK0245MK
Reference: 02K4502
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 07:40

Manufacturer products View details

ARCHITECT

Architect Free T3

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740144791
Basic UDI-DI: 038074ARK0763NE
Reference: 07K6302
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 07:40

Manufacturer products View details

ARCHITECT

ARCHITECT CA 15-3

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740145293
Basic UDI-DI: 038074ARK0244MH
Reference: 02K4402
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 07:40

Manufacturer products View details

ARCHITECT

ARCHITECT CA19-9XR

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740137151
Basic UDI-DI: 038074ARK0291MS
Reference: 02K9124
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 07:40

Manufacturer products View details

ARCHITECT

ARCHITECT Total T4

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740129453
Basic UDI-DI: 038074ARK0766NL
Reference: 07K6602
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT BHCG

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014933
Basic UDI-DI: 038074AIK0778K6
Reference: 07K7801
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 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT Prolactin

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014834
Basic UDI-DI: 038074ARK0776NP
Reference: 07K7601
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 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT FSH

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014780
Basic UDI-DI: 038074ARK0775NM
Reference: 07K7501
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT Total PSA

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740014599
Basic UDI-DI: 038074ARK0770NB
Reference: 07K7001
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

Architect CEA

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740014544
Basic UDI-DI: 038074ARK0768NQ
Reference: 07K6802
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT Free T4

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014360
Basic UDI-DI: 038074ARK0765NJ
Reference: 07K6510
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT Total T3

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014346
Basic UDI-DI: 038074ARK0764NG
Reference: 07K6450
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

Architect TSH

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014209
Basic UDI-DI: 038074ARK0762NC
Reference: 07K6201
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:38

Manufacturer products View details

ARCHITECT

ARCHITECT Ferritin

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014070
Basic UDI-DI: 038074ARK0759NP
Reference: 07K5901
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 07:38

Manufacturer products View details

QuikRead go easy CRP

IVD Class CNot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001430
Basic UDI-DI: 6438115QRgoeasyCRPJP
Reference: 153287
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 23.09.2026 07:07

Manufacturer products View details

Alinity

Alinity i Folate

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740130626
Basic UDI-DI: 038074AIP0814L8
Reference: 08P1542
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:30

Manufacturer products View details

Alinity

Alinity i Pepsinogen II

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740147563
Basic UDI-DI: 038074AIP0925LJ
Reference: 09P2501
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:30

Manufacturer products View details