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348 device results listed.

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08435287108989

D-DIMER CONTROLS I / II

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108989
Basic UDI-DI: B-08435287108989
Reference: 18078
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08435287100273

FIBRINOGEN STANDARD

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287100273
Basic UDI-DI: B-08435287100273
Reference: 31601
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:40

Manufacturer products View details

08435287100266

FIBRINOGEN CONTROL PLASMA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287100266
Basic UDI-DI: B-08435287100266
Reference: 31602
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:40

Manufacturer products View details

INNOVANCE Rivaroxaban Standards

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414240367
Basic UDI-DI: 0405686902002UM
Reference: 10873677
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 07.07.2026 15:37

Manufacturer products View details

Coagulation Control P

IVD generalIVDDNo longer on the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100048888
Basic UDI-DI: B-07798100048888
Reference: 1937005
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation Control N

IVD generalIVDDNo longer on the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100048871
Basic UDI-DI: B-07798100048871
Reference: 1937004
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Control Plasma Pathologic

Plasma Control Patológico

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100043746
Basic UDI-DI: B-07798100043746
Reference: 42006
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Control Plasma Normal

Plasma Control Normal

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100043739
Basic UDI-DI: B-07798100043739
Reference: 42005
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Plasma Control Patológico

IVD generalIVDDNo longer on the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100043333
Basic UDI-DI: B-07798100043333
Reference: 1937002
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Plasma Control Normal

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100043326
Basic UDI-DI: B-07798100043326
Reference: 1937001
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:10

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation Calibrator

IVD generalIVDDNo longer on the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100040417
Basic UDI-DI: B-07798100040417
Reference: 1705007
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:10

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07791778046279
Basic UDI-DI: B-07791778046279
Reference: 42007
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Pefaclot® UFH Controls

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Pentapharm AG
Manufacturer SRN: CH-MF-000020620
UDI-DI: 07640175460075
Basic UDI-DI: B-07640175460075
Reference: 505-60
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

APCr Controls

APC Resistance Controls

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Pentapharm AG
Manufacturer SRN: CH-MF-000020620
UDI-DI: 07613336155455
Basic UDI-DI: B-07613336155455
Reference: 08045232190
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

CoaguDx Quality Control

Level 1：6 vial×1 mL Level 2：6 vial×1 mL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896413645
Basic UDI-DI: B-06978896413645
Reference: W-CL1-QC-6
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

CoaguDx Quality Control

Level 1：3 vial×1 mL Level 2：3 vial×1 mL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896413638
Basic UDI-DI: B-06978896413638
Reference: W-CL1-QC-3
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

CoaguDx Quality Control

Level 1：2 vial×1 mL Level 2：2 vial×1 mL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896413621
Basic UDI-DI: B-06978896413621
Reference: W-CL1-QC-2
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

CoaguDx Quality Control

Level 1：1 vial×1 mL Level 2：1 vial×1 mL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896413614
Basic UDI-DI: B-06978896413614
Reference: W-CL1-QC-1
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Antithrombin III Control

CTRL-AT III,10×1.0 mL (low value), 10×1.0 mL (high value)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454729
Basic UDI-DI: B-06976117454729
Reference: NX-0017-06
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 07.07.2026 00:31

Manufacturer products Authorised representative products Authorised representative actors View details

Antithrombin III Control

CTRL-AT III,1×1.0 mL (low value), 1×1.0 mL (high value)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454712
Basic UDI-DI: B-06976117454712
Reference: NX-0017-05
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 07.07.2026 00:31

Manufacturer products Authorised representative products Authorised representative actors View details