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

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45 device results listed.

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Autokit 3-HB R1 Set

998-73501, 994-73601

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164789
Basic UDI-DI: 49874814987481164789VS
Reference: 998-73501
EMDN: -
EMDN description: SUBSTRATES - OTHER
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako DCP

995-60701, 999-61201, 995-61301, 991-61401

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164413
Basic UDI-DI: 49874814987481164413UA
Reference: 995-60701
EMDN: -
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3

999-60601, 997-60901, 997-61001, 993-61101

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164390
Basic UDI-DI: 49874814987481164390UP
Reference: 999-60601
EMDN: -
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

LAL Control

993-04201, 997-04101, 995-04401

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481163829
Basic UDI-DI: 498748114987481163802ZB
Reference: 995-04401
EMDN: -
EMDN description: MYCOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

β-Glucan Test R1: Pretreatment Solution

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481163802
Basic UDI-DI: 498748114987481163802ZB
Reference: 993-04201
EMDN: W0105060304
EMDN description: MYCOLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

BC Tip 1000-R

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481163871
Basic UDI-DI: 49874811498748116386424
Reference: 991-05101
EMDN: W0503020202
EMDN description: PIPETTES, TIPS WITHOUT FILTER
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3 Control H

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164458
Basic UDI-DI: 49874814987481164390UP
Reference: 993-61101
EMDN: W0102152005
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako DCP Control H

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164496
Basic UDI-DI: 49874814987481164413UA
Reference: 991-61401
EMDN: W0102152005
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type Direct Bilirubin Reagent 2

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164908
Basic UDI-DI: 4987481149874811648922G
Reference: 996-24191
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type Total Bilirubin Reagent 2

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164922
Basic UDI-DI: 49874811498748116491523
Reference: 998-24391
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type HDL-C Reagent 1

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165028
Basic UDI-DI: 498748114987481165028Z3
Reference: 999-73391
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type HDL-C Reagent 2

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165035
Basic UDI-DI: 498748114987481165028Z3
Reference: 995-73491
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type LDL-C Reagent 2

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165073
Basic UDI-DI: 498748114987481165066ZB
Reference: 994-25091
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3 Calibrator Set

IVD Class CNot specifiedOn the market

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164437
Basic UDI-DI: 49874814987481164390UP
Reference: 997-60901
EMDN: -
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako DCP Calibrator Set

IVD Class CNot specifiedOn the market

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164475
Basic UDI-DI: 49874814987481164413UA
Reference: 999-61201
EMDN: -
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Autokit 3-HB R2 Set