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06935091676480

Urine Analyzer Cleaner II

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingKitProfessional testingReagent

Manufacturer: Qingdao Hightop Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000016890
UDI-DI: 06935091676480
Basic UDI-DI: 69350916HT423MH
Reference: H4022
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06935091676466

Urine Analyzer Cleaner I

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingKitProfessional testingReagent

Manufacturer: Qingdao Hightop Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000016890
UDI-DI: 06935091676466
Basic UDI-DI: 69350916HT422MF
Reference: H4021
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06935091676473

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingKitProfessional testingReagent

Manufacturer: Qingdao Hightop Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000016890
UDI-DI: 06935091676473
Basic UDI-DI: 69350916HT422MF
Reference: H4021
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Acid Clean Flex reagent cartridge

IVDR_67_GLA_DUB-C_A_REAG_ACLN

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768037771
Basic UDI-DI: 0405686901026UU
Reference: 10712182
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Extra wash kit (350mL)

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155006807
Basic UDI-DI: 8430155SOLUCIONLAVADOFK
Reference: 990186
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 20.07.2026 07:36

Manufacturer products View details

ELUENT 80CT

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71292HB
Basic UDI-DI: B-71292HB
Reference: 71292
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80CT

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71291H9
Basic UDI-DI: B-71291H9
Reference: 71291
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80CV

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71279HK
Basic UDI-DI: B-71279HK
Reference: 71279
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80CV

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71278HH
Basic UDI-DI: B-71278HH
Reference: 71278
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

CONTROL DILUTION SET 80

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71277HF
Basic UDI-DI: B-71277HF
Reference: 71277
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

HEMOLYSIS WASHING SOLUTION 80H

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71276HD
Basic UDI-DI: B-71276HD
Reference: 71276
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80B

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71275HB
Basic UDI-DI: B-71275HB
Reference: 71275
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80A

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71274H9
Basic UDI-DI: B-71274H9
Reference: 71274
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

CONTROL DILUTION SET 80

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71265H8
Basic UDI-DI: B-71265H8
Reference: 71265
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

HEMOLYSIS WASHING SOLUTION 80H

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71264H6
Basic UDI-DI: B-71264H6
Reference: 71264
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80B

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71263H4
Basic UDI-DI: B-71263H4
Reference: 71263
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80A

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71262H2
Basic UDI-DI: B-71262H2
Reference: 71262
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-30A3

Sialic acid (SA) Test Kit (Enzymatic Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-30A3
Basic UDI-DI: B-6-30A3
Reference: "REF: U89582020M, U89582030M, U89589060M, U89585015M, U89511020M, U89520045M"
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-27AE

Carbon Dioxide Reagent Kit (PEPC Enzymatic Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-27AE
Basic UDI-DI: B-6-27AE
Reference: "REF: U85581020M, U85589050M, U85585020M, U85511020M"
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-23A6

β-Hydroxybutyrate (β-Hb）Test Kit (β-Hydroxybutyrate Dehydrogenase Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-23A6
Basic UDI-DI: B-6-23A6
Reference: "REF: U84082040M, U84089060M, U84085020M, U84011020M, U84020060M"
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:12

Manufacturer products Authorised representative products Authorised representative actors View details