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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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AFT-ISE

IVD Class AIVDR 2017/746Not intended for EU marketProfessional testingReagent

Manufacturer: Meizhou Cornley Hi-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000025014
UDI-DI: 06947929500096
Basic UDI-DI: 69479295AFT-ISE2M
Reference: AFT-ISE(R1:for K + ,Na + ,Cl -,Ca 2+ ,pH)
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
First on market country: -
Authorised representative: Caretechion GmbH
Last updated: 21.09.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Enzymatic Creatinine Flex reagent cartridge

DX_LS_LEGACY_00842768036262

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768036262
Basic UDI-DI: B-00842768036262
Reference: 10700444
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Urinary/Cerebrospinal Fluid Protein Flex reagent cartridge

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IVD generalNot specifiedOn the market

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768015502
Basic UDI-DI: B-00842768015502
Reference: 10445168
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235290
Basic UDI-DI: 69422022W010106029903R0ES
Reference: 3025776
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.09.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235283
Basic UDI-DI: 69422022W010106029903R0ES
Reference: 3025764
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.09.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235276
Basic UDI-DI: 69422022W010106029903R0ES
Reference: 3025772
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.09.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235269
Basic UDI-DI: 69422022W010106029903R0ES
Reference: 3025777
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.09.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235252
Basic UDI-DI: 69422022W010106029903R0ES
Reference: 3025768
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.09.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235245
Basic UDI-DI: 69422022W010106029903R0ES
Reference: 3025775
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.09.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235238
Basic UDI-DI: 69422022W010106029903R0ES
Reference: 3025780
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.09.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235221
Basic UDI-DI: 69422022W010106029903R0ES
Reference: 3025779
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.09.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

Copper

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SENTINEL CH. S.p.A.
Manufacturer SRN: IT-MF-000012556
UDI-DI: 00380740010867
Basic UDI-DI: B-00380740010867
Reference: 6K93-30
EMDN: W01010206
EMDN description: COPPER
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 23:04

Manufacturer products View details

FastPack Control Kit International

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020136
Basic UDI-DI: B-00816467020136
Reference: 25000065
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

FastPack Testo Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020044
Basic UDI-DI: B-00816467020044
Reference: 25000014
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Tract Infections Test

Urinary Tract Infections Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 00764451120839
Basic UDI-DI: B-00764451120839
Reference: U031-04H-001
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Enzymatic Creatinine_2

DX_LS_LEGACY_00630414595795

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595795
Basic UDI-DI: B-00630414595795
Reference: 11097533
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry Urea Nitrogen Reagents, Concentrated

DX_LS_LEGACY_00630414553214

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414553214
Basic UDI-DI: B-00630414553214
Reference: 10283349
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry Creatinine Reagents, Concentrated

DX_LS_LEGACY_00630414553184

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414553184
Basic UDI-DI: B-00630414553184
Reference: 10283346
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry Carbon Dioxide Reagent, Concentrated

DX_LS_LEGACY_00630414553177

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414553177
Basic UDI-DI: B-00630414553177
Reference: 10283345
EMDN: W01010302
EMDN description: BICARBONATE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry Total Protein II Reagents, Concentrated

DX_LS_LEGACY_00630414553207

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414553207
Basic UDI-DI: B-00630414553207
Reference: 10283348
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details