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BioLyse-BASO-2 Basophil reagent 1L

BioLyse-BASO-2

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862176822
Basic UDI-DI: 5999862176BL-BASO-2CT9Y
Reference: CT-2015
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 04.08.2026 21:58

Manufacturer products View details

SEDiTROL

SEDiTROL ESR Controls

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Alcor Scientific
Manufacturer SRN: US-MF-000029295
UDI-DI: 00896406002492
Basic UDI-DI: 0896406002SEDiTROLC4
Reference: DSC06
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 560 Control

IVDR_67_TTN_DUB-C_B_REAG_Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600840
Basic UDI-DI: 0405686901690W3
Reference: 11170854
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i 3 in 1 TESTpoint CSF Controls

IVDR_67_TTN_DUB-C_B_REAG_CSF Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472539
Basic UDI-DI: 0405686900782W2
Reference: 10314243
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Reticulocyte Controls (Low)

IVDR_67_TTN_DUB-C_B_REAG_Reticulocyte Control High

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224428
Basic UDI-DI: 0405686900796WD
Reference: 10312293
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Hematology Controls (High)

IVDR_67_TTN_DUB-C_B_REAG_Control High

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224404
Basic UDI-DI: 0405686900779WD
Reference: 10312291
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Hematology Controls (Norm)

IVDR_67_TTN_DUB-C_B_REAG_Control Normal

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224381
Basic UDI-DI: 0405686900781VY
Reference: 10312289
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Hematology Controls (Low)

IVDR_67_TTN_DUB-C_B_REAG_Control Low

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224367
Basic UDI-DI: 0405686900780VW
Reference: 10312287
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Cell Count™ kit

Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: IQ Products BV
Manufacturer SRN: NL-MF-000010812
UDI-DI: 08717953022332
Basic UDI-DI: B-08717953022332
Reference: IQP-363
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Netherlands
Authorised representative: -
Last updated: 04.08.2026 11:17

Manufacturer products View details

Fecal Occult Blood (FOB) Test Kit (LIA)

Hitachi 7020, 7180, Beckman AU680,OC-Sensor IO

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Hehao Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000029298
UDI-DI: 06975867980014
Basic UDI-DI: B-06975867980014
Reference: BQX2
EMDN: W0103010201
EMDN description: HAEMOGLOBIN DETERMINATIONS (TOTAL HB)
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 04.08.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

ED-30D Control N

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413815766
Basic UDI-DI: B-06944413815766
Reference: ED-30D Control N
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

ED-30D Control H

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413815759
Basic UDI-DI: B-06944413815759
Reference: ED-30D Control H
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Calibrator

ED-CAL PLUS

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814127
Basic UDI-DI: B-06944413814127
Reference: ED-CAL PLUS
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

06941571844003

R44-112

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571844003
Basic UDI-DI: B-06941571844003
Reference: R44-112
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:55

Manufacturer products Authorised representative products Authorised representative actors View details

06941571840234

R40-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571840234
Basic UDI-DI: B-06941571840234
Reference: R40-112-01
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Spain
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:55

Manufacturer products Authorised representative products Authorised representative actors View details

06941571840227

R402-112

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571840227
Basic UDI-DI: B-06941571840227
Reference: R402-112
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:55

Manufacturer products Authorised representative products Authorised representative actors View details

06941571840302

R40-112

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571840302
Basic UDI-DI: B-06941571840302
Reference: R40-112
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:55

Manufacturer products Authorised representative products Authorised representative actors View details

06941571840210

R40S-112

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571840210
Basic UDI-DI: B-06941571840210
Reference: R40S-112
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

06941571840203

R40-112

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571840203
Basic UDI-DI: B-06941571840203
Reference: R40-112
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

06941571840111

R40S-110

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571840111
Basic UDI-DI: B-06941571840111
Reference: R40S-110
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details