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25 device results listed.

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D-CNMF000014455-BF-C063N7

BF C06

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C063N7
Basic UDI-DI: B-CNMF000014455-BF-C063N7
Reference: BF-C063
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C062N5

BF C06

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C062N5
Basic UDI-DI: B-CNMF000014455-BF-C062N5
Reference: BF-C062
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C061N3

BF C06

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C061N3
Basic UDI-DI: B-CNMF000014455-BF-C061N3
Reference: BF-C061
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

PT (INR) control kit

IVD generalIVDDOn the marketHuman tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST1800E4
Basic UDI-DI: B-ST1800E4
Reference: ST1800
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:43

Manufacturer products View details

D-Dimer control kit

IVD generalIVDDOn the marketHuman tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST1500DM
Basic UDI-DI: B-ST1500DM
Reference: ST1500
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:43

Manufacturer products View details

D-Dimer Control

FDDDI-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDDDI-PN20YZ
Basic UDI-DI: B-FDDDI-PN20YZ
Reference: FDDDI-PN20
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Control

FDDDI-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDDDI-PN20HG3D
Basic UDI-DI: B-FDDDI-PN20HG3D
Reference: FDDDI-PN20
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

TruHemo

Coag Abnormal Control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245127
Basic UDI-DI: B-15065026245127
Reference: TH10010
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

TruHemo

Coag Normal Control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245110
Basic UDI-DI: B-15065026245110
Reference: TH10009
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

RAMP Total b-hCG Controls Level 1

RAMP Total b-hCG Controls - Level 1 (C4003-1)

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Response Biomedical Corp.
Manufacturer SRN: CA-MF-000034747
UDI-DI: 10627966005312
Basic UDI-DI: B-10627966005312
Reference: C4003-1
EMDN: W010302080502
EMDN description: HAEMOSTASIS STANDARDS AND CALIBRATORS RT & POC
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 02:21

Manufacturer products Authorised representative products Authorised representative actors View details

RAMP Total b-hCG Controls Level 2

RAMP Total b-hCG Controls - Level 2 (C4003-2)

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Response Biomedical Corp.
Manufacturer SRN: CA-MF-000034747
UDI-DI: 10627966005282
Basic UDI-DI: B-10627966005282
Reference: C4003-2
EMDN: W010302080502
EMDN description: HAEMOSTASIS STANDARDS AND CALIBRATORS RT & POC
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 02:21

Manufacturer products Authorised representative products Authorised representative actors View details

06975838801232

1ml*10

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838801232
Basic UDI-DI: B-06975838801232
Reference: HE50124
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

06975838801225

1ml*10

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838801225
Basic UDI-DI: B-06975838801225
Reference: HE50003
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® Multi-level Coag Controls

QS-6-CL Pro

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703160764
Basic UDI-DI: B-06974703160764
Reference: QS-6-CL Pro
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® APTT Liquid Control

QS-9-CL Pro

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703160207
Basic UDI-DI: B-06974703160207
Reference: QS-9-CL Pro
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® Coag Panel 2 Liquid Control

QS-4-CL Pro

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703160191
Basic UDI-DI: B-06974703160191
Reference: QS-4-CL Pro
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® PT-INR Liquid Control

QS-1-CL Pro

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703160184
Basic UDI-DI: B-06974703160184
Reference: QS-1-CL Pro
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

QuikRead CRP Control

IVD generalNot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001645
Basic UDI-DI: B-06438115001645
Reference: 154812
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:08

Manufacturer products View details

QuikRead go HbA1c Control Set

IVD generalNot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001560
Basic UDI-DI: B-06438115001560
Reference: 154520
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:08

Manufacturer products View details

QuikRead go CRP Control Low

IVD generalNot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001515
Basic UDI-DI: B-06438115001515
Reference: 153765
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:08

Manufacturer products View details