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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

XL CLEANER

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156186025
Basic UDI-DI: 8592156CCOR0054WG
Reference: XSYS0125
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

XL WASH

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156081115
Basic UDI-DI: 8592156CCORW0546V
Reference: XSYS0066
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

XL ISE CLEAN

XL ISE CLEANING

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156081009
Basic UDI-DI: 8592156CCOR0055WJ
Reference: XSYS0062
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

PDP 50

PYRIDOXAL-5-PHOSPHATE 50

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156001410
Basic UDI-DI: 8592156CCRE0057TE
Reference: 10,003,294
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

XL URINE DIL

XL Urine Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156085601
Basic UDI-DI: 8592156CC0RD055NH
Reference: XSYS0067
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:26

Manufacturer products View details

Odczynnik sulfosalicylowy do wykrywania białka w moczu 500ml