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iFlash-IL-6

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719342
Basic UDI-DI: 692591270151H7
Reference: C86142
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-D-dimer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711360
Basic UDI-DI: 692591270152H9
Reference: C86238
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

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BF-WFF Dye

Hematology Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577641
Basic UDI-DI: 69257945W0103010199R0PF
Reference: 3019941
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

FE Dye

1. Dye A: 1×50mL/bottle; Dye B: 1× 50mL/bottle 2. Dye A: 1×100mL/bottle, Dye B: 1×100mL/bottle 3. Dye A: 1×200mL/bottle, Dye B: 1×200mL/bottle 4. Dye A: 1×400mL/bottle, Dye B: 1×400mL/bottle 5. Dye A: 1×500mL/bottle, Dye B: 1×500mL/bottle

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577580
Basic UDI-DI: 69257945W01030702R0ZM
Reference: 3019942
EMDN: W01030702
EMDN description: CYTOCHEMICAL STAINING REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

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Sample Diluent

Blood Coagulation

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577542
Basic UDI-DI: 69257945W0103020903R0PT
Reference: 3019961
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Blood Coagulation Analyzer Detergent II

Automatic Blood Coagulation Analyzer Detergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577511
Basic UDI-DI: 69257945W0103020999R0SQ
Reference: 3019962
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

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Probe Cleanser(BCC-3000)

Hematology Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794501684
Basic UDI-DI: 69257945W0103010105R0LU
Reference: 3002433
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

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BT Liss

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Shanghai Runpu Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000027207
UDI-DI: 06925661508013
Basic UDI-DI: 69256615XSY01Z9
Reference: 2501-00085-01
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:27

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Mission 3D Hematology Reagent (Cyto-Lyser)

3D Hematology Reagent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756496487
Basic UDI-DI: 6921756499990030WW
Reference: C121-9021-201
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 18:10

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Kit for Determination of the DNA Fragmentation level in Spermatozoa (SCD method)

Kit for determination of the DNA fragmentation level in spermatozoa (SCD method)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BRED Life Science Technology Inc.
Manufacturer SRN: CN-MF-000037518
UDI-DI: 06920234700238
Basic UDI-DI: 69202347BRED002CL
Reference: 20 tests/kit
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 31.07.2026 18:05

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Diatro•Hypoclean

D701

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586204
Basic UDI-DI: 5999883586HYPY9
Reference: D7011
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:47

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BioStain RET fluorescent reticulocyte 12mL

BioStain RET

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366629
Basic UDI-DI: 5999862176BioStainRETAK
Reference: S021
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

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BioStain NRBC fluorescent NRBC 12mL

BioStain NRBC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366612
Basic UDI-DI: 5999862366BioStainNRBCZT
Reference: S024
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

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BioStain W5P fluorescent WBC-5-diff dye 42mL

BioStain W5P

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366605
Basic UDI-DI: 5999862366BioStainW5PB4
Reference: S028
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioLyse W5P WBC-5-diff lysing reagent 5L

BioLyse W5P

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366599
Basic UDI-DI: 5999862366BioLyseW5PP8
Reference: L027
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioLyse NRBC NRBC specific lysing reagent 1L

BioLyse NRBC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366582
Basic UDI-DI: 5999862366BioLyseNRBC96
Reference: L021
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioDil RET reticulocyte buffer 1L

BioDil RET

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366575
Basic UDI-DI: 5999862366BioDilRETZA
Reference: BioDil RET reticulocyte buffer 1L
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioDil SWE diluent 10L

BioDil SWE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366551
Basic UDI-DI: 5999862366BioDilSWE2A
Reference: SW-1115
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioLyse SW WBC-3-diff lysing reagent 1L

BioLyse SW

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366537
Basic UDI-DI: 5999862366BioLyseSWFC
Reference: SW-2151
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioClean M22 cleaning reagent 1L

BioClean M22

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366520
Basic UDI-DI: 5999862366BioCleanM22QG
Reference: OM-5061
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details