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22.09.2026 08:45

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76 device results listed.

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QuikRead go wrCRP+Hb

IVD generalNot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115000990
Basic UDI-DI: B-06438115000990
Reference: 146255
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Finland
Authorised representative: -
Last updated: 22.09.2026 06:23

Manufacturer products View details

MPV Quantitative Test (Realtime PCR)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208838
Basic UDI-DI: B-06933260208838
Reference: BT0300301
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Hemo Control Hemoglobin Microcuvette

Hemo Control Hemoglobin Microcuvettes

IVD Class BIVDR 2017/746Not intended for EU marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: EKF-diagnostic GmbH
Manufacturer SRN: DE-MF-000006416
UDI-DI: 44048534002453
Basic UDI-DI: 4048534AFBBVE
Reference: 3000-3112-02
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 05:02

Manufacturer products 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

06941571840104

R40-110

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571840104
Basic UDI-DI: B-06941571840104
Reference: R40-110
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

One-Step Immunological Fecal Occult Blood Test

Strip; Cassette

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-6909620WHSFOB8VJY
Basic UDI-DI: B-6909620WHSFOB8VJY
Reference: WH-FOB-S0x0101; WH-FOB-S0x0102
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE HbA1c Disc

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001218B
Basic UDI-DI: ++G322G322001218BL8MB
Reference: 001-218B
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

LTA Check Test Kit

LTA Check Test Kit (Performance Monitoring)

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561071171/ $$0100365XXXXX/*
Basic UDI-DI: ++G0561071174F
Reference: 107117
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

vW Select (Ristocetin Cofactor Activity Assay Test System)

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561067301/ $$0100343XXXXX-*
Basic UDI-DI: ++G0561067304W
Reference: 106730
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

vW Factor Assay® Ristocetin Cofactor Assay Test Kit

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561030251/ $$0100262XXXXXU*
Basic UDI-DI: ++G0561030253D
Reference: 103025
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Lyophilized Platelets

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561012580/ $$0100060XXXX+*
Basic UDI-DI: ++G0561012583Q
Reference: 101258
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® Hb/Hp Complex plus Test

Hb/Hp Complex plus Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-272011N-25W8
Basic UDI-DI: B-nvm-272011N-25W8
Reference: 272011N-25
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

D-K91201-0448

EFT-B

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K91201-0448
Basic UDI-DI: B-K91201-0448
Reference: /
EMDN: W0103010602
EMDN description: ERYTHROCYTES (ERY)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Hb Hemoglobin Test Strip

BK-H2

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-H2SR
Basic UDI-DI: B-BK-H2SR
Reference: BK-H2
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details