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HbA2 & HbF & HbA1c Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152423
Basic UDI-DI: B-06977125152423
Reference: GHDDM1
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

HbA2 & HbF & HbA1c Assay Kit (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152416
Basic UDI-DI: B-06977125152416
Reference: GHD200
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

HbA2 & HbF & HbA1c Assay Kit (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152409
Basic UDI-DI: B-06977125152409
Reference: GHD100
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

06976894950230

UQ001

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894950230
Basic UDI-DI: B-06976894950230
Reference: UQ001010
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

06976894950209

UQ001

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894950209
Basic UDI-DI: B-06976894950209
Reference: UQ001025
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

06976894950179

UQ001

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894950179
Basic UDI-DI: B-06976894950179
Reference: UQ001050
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

06976894950148

UQ001

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894950148
Basic UDI-DI: B-06976894950148
Reference: UQ001100
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

06976894950117

LQ001

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894950117
Basic UDI-DI: B-06976894950117
Reference: LQ001010
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

06976894950087

LQ001

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894950087
Basic UDI-DI: B-06976894950087
Reference: LQ001025
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

06976894950056

LQ001

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894950056
Basic UDI-DI: B-06976894950056
Reference: LQ001050
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

06976894950025

LQ001

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894950025
Basic UDI-DI: B-06976894950025
Reference: LQ001100
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

L-3D： High: 2.5mL/Vial

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180656
Basic UDI-DI: B-06976578180656
Reference: 0320900209
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

L-3D：Normal: 2.5mL/Vial

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180649
Basic UDI-DI: B-06976578180649
Reference: 0320900208
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

L-5D：High: 3mL/Vial

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180632
Basic UDI-DI: B-06976578180632
Reference: 0320900213
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

L-5D：Normal: 3mL/Vial

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180625
Basic UDI-DI: B-06976578180625
Reference: 0320900212
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

L-5D：Mix: 3mL/Vial

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180618
Basic UDI-DI: B-06976578180618
Reference: 0320900214
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

L-3D： Mix: 2.5mL/Vial

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180601
Basic UDI-DI: B-06976578180601
Reference: 0320900210
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Calibrator

L-CAL：3mL×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180083
Basic UDI-DI: B-06976578180083
Reference: 0320900302
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

L-3D：Low: 2.5mL/Vial

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180076
Basic UDI-DI: B-06976578180076
Reference: 0320900207
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

L-5D：Low: 3mL/Vial

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Wheisman Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045463
UDI-DI: 06976578180069
Basic UDI-DI: B-06976578180069
Reference: 0320900211
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details