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BIOPHEN™ Orgaran® Calibrator

Danaparoid Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008269
Basic UDI-DI: 366353700015B2
Reference: 222201
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

BIOPHEN™ Heparin Calibrator

Heparin Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008245
Basic UDI-DI: 366353700014AY
Reference: 222001
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

BIOPHEN™ UFH Control C2

UFH Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537007996
Basic UDI-DI: 366353700038BE
Reference: 223901
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

BIOPHEN™ LMWH Control C3

LMWH Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537007989
Basic UDI-DI: 366353700033B4
Reference: 223801
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

SmarLumi

Thrombin-Antithrombin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857918
Basic UDI-DI: B-06933289857918
Reference: W392P0007
EMDN: W0103020307
EMDN description: THROMBIN-ANTITHROMBIN III-COMPLEX
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Thrombin-Antithrombin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857901
Basic UDI-DI: B-06933289857901
Reference: W392P0006
EMDN: W0103020307
EMDN description: THROMBIN-ANTITHROMBIN III-COMPLEX
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Thrombin-Antithrombin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857895
Basic UDI-DI: B-06933289857895
Reference: W392P0005
EMDN: W0103020307
EMDN description: THROMBIN-ANTITHROMBIN III-COMPLEX
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Thrombin-Antithrombin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857888
Basic UDI-DI: B-06933289857888
Reference: W392P0004
EMDN: W0103020307
EMDN description: THROMBIN-ANTITHROMBIN III-COMPLEX
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Thrombomodulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857871
Basic UDI-DI: B-06933289857871
Reference: W391P0007
EMDN: W0103020399
EMDN description: SPECIAL COAGULATION TESTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Thrombomodulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857864
Basic UDI-DI: B-06933289857864
Reference: W391P0006
EMDN: W0103020399
EMDN description: SPECIAL COAGULATION TESTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Thrombomodulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857857
Basic UDI-DI: B-06933289857857
Reference: W391P0005
EMDN: W0103020399
EMDN description: SPECIAL COAGULATION TESTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Thrombomodulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857840
Basic UDI-DI: B-06933289857840
Reference: W391P0004
EMDN: W0103020399
EMDN description: SPECIAL COAGULATION TESTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Revohem™ Rivaroxaban Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537086205
Basic UDI-DI: 366353700037BC
Reference: BB808578
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

Revohem™ Fondaparinux Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537086632
Basic UDI-DI: 366353700009B7
Reference: CW731055
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

BIOPHEN™ Edoxaban Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082399
Basic UDI-DI: 366353700013AW
Reference: 226501
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

Revohem™ UFH Control Plasma

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537086212
Basic UDI-DI: 366353700038BE
Reference: AZ296682
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

Revohem™ AT LRT

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085321
Basic UDI-DI: 366353700053BA
Reference: AB751585
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

Revohem™ Danaparoid Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537086625
Basic UDI-DI: 366353700015B2
Reference: CE707939
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

Revohem™ Danaparoid Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537086618
Basic UDI-DI: 366353700036BA
Reference: CJ744965
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

BIOPHEN™ Heparin LRT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537057915
Basic UDI-DI: 366353700059BN
Reference: 221013
EMDN: W0103020309
EMDN description: ANTI XA ACTIVITY FOR HEPARIN AND DOAC
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details