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D-Dimer Rapid Test

CDDg002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CDDg00CF
Basic UDI-DI: B-CDDg00CF
Reference: CDDg002
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 08:11

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

D-Dimer (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857673
Basic UDI-DI: B-06933289857673
Reference: W386P0007
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

D-Dimer (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857666
Basic UDI-DI: B-06933289857666
Reference: W386P0006
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

D-Dimer (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857659
Basic UDI-DI: B-06933289857659
Reference: W386P0005
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

D-Dimer (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857642
Basic UDI-DI: B-06933289857642
Reference: W386P0004
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

Revohem™ FVIII Bovine

Factor VIII (FVIII) bovine

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537087165
Basic UDI-DI: 366353700097BW
Reference: CQ907801
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ Edoxaban Calibrator Low

Edoxaban Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082382
Basic UDI-DI: 366353700013AW
Reference: 226401
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ Edoxaban Control Low

Edoxaban Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082368
Basic UDI-DI: 366353700031AY
Reference: 225401
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

LIAPHEN™ vWF: Ag

Von Willebrand Factor Antigen (vWF: Ag)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082320
Basic UDI-DI: 366353700006AZ
Reference: 120206
EMDN: W0103020215
EMDN description: COAGULATION FACTOR VON WILLEBRAND (AG)
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ AT anti-(h)-Xa LRT

Antithrombin (AT) activity - AntiXa

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537072253
Basic UDI-DI: 366353700053BA
Reference: 221123
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ DiXaI

Direct Factor Xa inhibitors (DiXaIs)

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537047633
Basic UDI-DI: 366353700054BC
Reference: 221030
EMDN: W0103020309
EMDN description: ANTI XA ACTIVITY FOR HEPARIN AND DOAC
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ Rivaroxaban Plasma Calibrator

Rivaroxaban Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537046445
Basic UDI-DI: 366353700017B6
Reference: 222701
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ Apixaban Control Low

Apixaban Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537068799
Basic UDI-DI: 366353700027B9
Reference: 225201
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™ Apixaban Calibrator Low

Apixaban Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537068775
Basic UDI-DI: 366353700008B5
Reference: 226101
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™ Rivaroxaban Control Plasma

Rivaroxaban Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537046421
Basic UDI-DI: 366353700037BC
Reference: 224501
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™ Heparin LRT

Factor Xa (FXa) inhibitors

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537045394
Basic UDI-DI: 366353700059BN
Reference: 221011
EMDN: W0103020309
EMDN description: ANTI XA ACTIVITY FOR HEPARIN AND DOAC
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

BIOPHEN™ Arixtra® Control Plasma

Fondaparinux Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537041723
Basic UDI-DI: 366353700028BB
Reference: 224001
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™ Arixtra® Calibrator

Fondaparinux Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537041716
Basic UDI-DI: 366353700009B7
Reference: 222501
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™ Orgaran® Control

Danaparoid Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008337
Basic UDI-DI: 366353700036BA
Reference: 223501
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™ UFH Calibrator

UFH Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008276
Basic UDI-DI: 366353700018B8
Reference: 222301
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