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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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MAU Quantitative Test Kit (Time-Resolved FIA)

FIHSA-102a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIHSA-102a3D
Basic UDI-DI: B-FIHSA-102a3D
Reference: FIHSA-102a
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

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AUTION Control Solution

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73806J4
Basic UDI-DI: B-73806J4
Reference: 73806
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

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AUTION Sticks 10PA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73621HN
Basic UDI-DI: B-73621HN
Reference: 73621
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION SCREEN Microalbumin/Creatinine

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73601HG
Basic UDI-DI: B-73601HG
Reference: 73601
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

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Uriflet S 9UB

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73597JJ
Basic UDI-DI: B-73597JJ
Reference: 73597
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

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AUTION Sticks 10EA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73594JC
Basic UDI-DI: B-73594JC
Reference: 73594
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

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AUTION Sticks 10EA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73591J6
Basic UDI-DI: B-73591J6
Reference: 73591
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION CHECK Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73527HV
Basic UDI-DI: B-73527HV
Reference: 73527
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION Sticks 10PA

IVD generalIVDDNo longer on the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73524HP
Basic UDI-DI: B-73524HP
Reference: 73524
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Uriflet S 9HA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73521HH
Basic UDI-DI: B-73521HH
Reference: 73521
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Uriflet S 10HB

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73520HF
Basic UDI-DI: B-73520HF
Reference: 73520
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Uriflet S 10HA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73519HW
Basic UDI-DI: B-73519HW
Reference: 73519
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Hungary
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS Urine Control Solution

IVD generalIVDDNo longer on the marketHuman tissuesNear-patient testingReagent

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BURS3Q
Basic UDI-DI: B-47136487608BURS3Q
Reference: S5800401 S5800402
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS Creatinine Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BCRTYV
Basic UDI-DI: B-47136487608BCRTYV
Reference: S5641012 S5641013
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS ACR Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BACRT2W
Basic UDI-DI: B-47136487608BACRT2W
Reference: S5641014 S5641015
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS Multi-Purpose Analyzer

IVD generalIVDDNo longer on the marketAnimal tissuesInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608B06P
Basic UDI-DI: B-47136487608B06P
Reference: S35010
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

SG Calibrator Set

Reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-31111EY
Basic UDI-DI: B-31111EY
Reference: 31111
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 11.07.2026 18:17

Manufacturer products View details

Test-Reagent for 5-hydroxyindoleacetic acid

0.5ml x100 pieces

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Chenkang Science&Technology Co., LTD
Manufacturer SRN: CN-MF-000031528
UDI-DI: 26935734968884
Basic UDI-DI: B-26935734968884
Reference: C015
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 15:43

Manufacturer products Authorised representative products Authorised representative actors View details

Uriflet S 9UB

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-23905GG
Basic UDI-DI: B-23905GG
Reference: 23905
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION Sticks 10EA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20286FJ
Basic UDI-DI: B-20286FJ
Reference: 20286
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details