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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Orphée SA
Manufacturer SRN: CH-MF-000050926
UDI-DI: 07640142480099
Basic UDI-DI: 764014248HM22-002YV
Reference: HM22-002-1
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: PZ CORMAY Spółka Akcyjna
Last updated: 03.07.2026 06:31

Manufacturer products Authorised representative products Authorised representative actors View details

CLEANER FOR MYTHIC 22

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Orphée SA
Manufacturer SRN: CH-MF-000050926
UDI-DI: 07640142480082
Basic UDI-DI: 764014248HM22-001YT
Reference: HM22-001-1
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: PZ CORMAY Spółka Akcyjna
Last updated: 03.07.2026 06:31

Manufacturer products Authorised representative products Authorised representative actors View details

DILUENT FOR MYTHIC 22

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Orphée SA
Manufacturer SRN: CH-MF-000050926
UDI-DI: 07640142480075
Basic UDI-DI: 764014248HM22-003YX
Reference: HM22-003-10
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: PZ CORMAY Spółka Akcyjna
Last updated: 03.07.2026 06:31

Manufacturer products Authorised representative products Authorised representative actors View details

Mythic 18-22 Enzymatic Cleaning Solution

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Orphée SA
Manufacturer SRN: CH-MF-000050926
UDI-DI: 07640142480051
Basic UDI-DI: 764014248HM18-0072X
Reference: HM18-007-1
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: PZ CORMAY Spółka Akcyjna
Last updated: 03.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

Mythic 18 Cyanide free Lytic solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Orphée SA
Manufacturer SRN: CH-MF-000050926
UDI-DI: 07640142480037
Basic UDI-DI: 764014248HM18-0082Z
Reference: HM18-008-1
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: PZ CORMAY Spółka Akcyjna
Last updated: 03.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

Mythic 18 Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Orphée SA
Manufacturer SRN: CH-MF-000050926
UDI-DI: 07640142480013
Basic UDI-DI: 764014248HM18-00933
Reference: HM18-009-10
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: PZ CORMAY Spółka Akcyjna
Last updated: 03.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

Medonic M-serie Diluent 20L

Medonic M-series reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040794043
Basic UDI-DI: 735004079A012YB
Reference: 1504122
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

Swelab AlfaDiluent, 900 cycles

Swelab Alfa reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040790175
Basic UDI-DI: 735004079A013YD
Reference: 1504124
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

06978556700023

Cleaning Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Tianjin Readybio Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000047939
UDI-DI: 06978556700023
Basic UDI-DI: 697855670B002KN
Reference: MC-Coulter
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Cell Test Reagent

JY-05：50 tests/kit

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Han Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000042919
UDI-DI: 26977216100146
Basic UDI-DI: 697721610010010001D4
Reference: 014
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

06977254770062

20 tests/kit, 50 tests/kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Hailife Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042748
UDI-DI: 06977254770062
Basic UDI-DI: 697725477R1005HC
Reference: R100502EN
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

06977254770031

20 tests/kit, 50tests/kit

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: Shenzhen Hailife Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042748
UDI-DI: 06977254770031
Basic UDI-DI: 697725477R1003H8
Reference: R100302EN
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

06976964666238

1L，10L

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: Hunan AccuBio Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041914
UDI-DI: 06976964666238
Basic UDI-DI: 697696466MS0010001BB
Reference: MS001102
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Türkiye
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent - Lyse

W-31L：250mL、250mL×3、500mL、500mL×3、1L

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180052
Basic UDI-DI: 697657818032060012J
Reference: 0320900104
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent - Diluent

W-31D：2L, 5L, 10L, 20L

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180045
Basic UDI-DI: 697657818032060042Q
Reference: 0320900402
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent - Probe Cleanser

50mL、50mL×2

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180038
Basic UDI-DI: 697657818032060062U
Reference: 0320900501
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent - Lyse

W-61LH：250mL、250mL×3、500mL、500mL×3、1L

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180021
Basic UDI-DI: 697657818032060032N
Reference: 0320900102
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent - Lyse

W-61LD：250mL、250mL×3、500mL、500mL×3、1L

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180014
Basic UDI-DI: 697657818032060022L
Reference: 0320900101
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent - Diluent

2L, 5L, 10L, 20L

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180007
Basic UDI-DI: 697657818032060052S
Reference: 0320900401
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaning Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Taho Future ( Tianjin ) Biotechnology Co.,Ltd
Manufacturer SRN: CN-MF-000037788
UDI-DI: 96976504950028
Basic UDI-DI: 697650495MCCoulter06RM
Reference: MC-Coulter
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details