Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

16.07.2026 10:03

Sync status

Successful

Device

2830817

Actor

47401

Certificate

3098

Filters

Show filters

Active filter:Authorised representative SRN:DE-AR-000011552

45 device results listed.

Page 1 / 3

CSV XML

NEFA Standard

994-91801, 990-91901, 991-91791

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165110
Basic UDI-DI: 49874814987481165120TX
Reference: 991-91791
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 16.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako DCP Control L

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: 14987481164489
Basic UDI-DI: 49874814987481164413UA
Reference: 995-61301
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 16.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3 Control L

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: 14987481164441
Basic UDI-DI: 49874814987481164390UP
Reference: 997-61001
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 16.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

β-Glucan Test R2: LAL Reagent

993-04201, 997-04101, 995-04401

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481163796
Basic UDI-DI: 498748114987481163802ZB
Reference: 997-04101
EMDN: W0105060304
EMDN description: BETA-D-GLUCAN (PAN-FUNGAL MARKERS)
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 16.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type LDL-C Reagent 1

994-24991, 994-25091, 998-24891

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165066
Basic UDI-DI: 498748114987481165066ZB
Reference: 994-24991
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

HDL-C Calibrator

999-73391, 995-73491, 993-73291

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165011
Basic UDI-DI: 498748114987481165028Z3
Reference: 993-73291
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

Bilirubin Calibrator

994-24491

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164939
Basic UDI-DI: 4987481149874811649392H
Reference: 994-24491
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type Total Bilirubin Reagent 1

992-24291, 998-24391

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164915
Basic UDI-DI: 49874811498748116491523
Reference: 992-24291
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type Direct Bilirubin Reagent 1

990-24091, 996-24191

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164892
Basic UDI-DI: 4987481149874811648922G
Reference: 990-24091
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

Ketone Body Calibrator 300

993-73791

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164823
Basic UDI-DI: 498748114987481164823ZS
Reference: 993-73791
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3 Sample Dilution Buffer

997-61501

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164465
Basic UDI-DI: 498748114987481164465ZN
Reference: 997-61501
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako Chip Cassette

993-61601

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164427
Basic UDI-DI: 498748114987481164427ZE
Reference: 993-61601
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako Wash Solution

991-60801

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164502
Basic UDI-DI: 498748114987481164502Z3
Reference: 991-60801
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

BC Tip EXT

995-05001, 991-05101

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481163864
Basic UDI-DI: 49874811498748116386424
Reference: 995-05001
EMDN: W0503020202
EMDN description: PIPETTES, TIPS WITHOUT FILTER
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

Aluminum Cap

995-04901

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481163857
Basic UDI-DI: 49874811498748116385727
Reference: 995-04901
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

β-Glucan Sample Diluent

999-04301

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481163819
Basic UDI-DI: 498748114987481163819ZU
Reference: 999-04301
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

Autokit Total Ketone Bodies R1 Set

996-73301, 992-73401

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164802
Basic UDI-DI: 49874814987481164802UR
Reference: 996-73301
EMDN: W01010299
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

NEFA-HR(2) R1 Set

994-91801, 990-91901, 991-91791

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481165120
Basic UDI-DI: 49874814987481165120TX
Reference: 994-91801
EMDN: -
EMDN description: NON ESTERIFIED FATTY ACIDS
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

Hyaluronic acid-LT Set

999-81101, 993-81001, 995-81201, 991-81301

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164970
Basic UDI-DI: 49874814987481164970VF
Reference: 999-81101
EMDN: -
EMDN description: HYALURONIC ACID
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

Autokit CH50 Set

993-40601, 999-40701, 993-43901, 993-44001

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164833
Basic UDI-DI: 49874814987481164833V4
Reference: 993-40601
EMDN: -
EMDN description: TOTAL COMPLEMENT ACTIVITY (CH50)
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