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23 device results listed.

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BIOPHEN™ FVIII

Factor VIII (FVIII) chromogenic

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537007972
Basic UDI-DI: 366353700058BL
Reference: 221402
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

BIOPHEN™ FVIII

Factor VIII (FVIII) chromogenic

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537047329
Basic UDI-DI: 366353700058BL
Reference: 221406
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

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Factor VIII DP

Factor VIII immunads. Deficient Plasma

IVD Class CIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860384
Basic UDI-DI: 912003686TC480000001Q4
Reference: 5154002
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Austria
Authorised representative: -
Last updated: 11.08.2026 23:01

Manufacturer products View details

Factor VIII DP

Factor VIII immunads. Deficient Plasma

IVD Class CIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860391
Basic UDI-DI: 912003686TC480000001Q4
Reference: 5154004
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Austria
Authorised representative: -
Last updated: 11.08.2026 23:01

Manufacturer products View details

Factor VIII DP native

Factor VIII native Deficient Plasma

IVD Class CIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860407
Basic UDI-DI: 912003686TC480000001Q4
Reference: 5154007
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Austria
Authorised representative: -
Last updated: 11.08.2026 23:01

Manufacturer products View details

Factor VIII DP native

Factor VIII native Deficient Plasma

IVD Class CIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860414
Basic UDI-DI: 912003686TC480000001Q4
Reference: 5154016
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Austria
Authorised representative: -
Last updated: 11.08.2026 23:01

Manufacturer products View details

Technochrom FVIII:C 2G

IVD Class CIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036864283
Basic UDI-DI: 912003686TC0N0000001ZP
Reference: 5344102
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Austria
Authorised representative: -
Last updated: 10.08.2026 22:47

Manufacturer products 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

Factor VIII Chromogenic Assay

IVDR_27_MAR EB_C_KIT_FVIII_Chrom

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640389
Basic UDI-DI: 0405686900866W9
Reference: 10873840
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:15

Manufacturer products View details

TEClot Factor VIII Deficient Plasma

FAC

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: TECO Medical Instruments, Production + Trading GmbH
Manufacturer SRN: DE-MF-000022642
UDI-DI: D-FAC-VIII-P5301-01097
Basic UDI-DI: B-FAC-VIII-P5301-01097
Reference: P5301-010
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Germany
Authorised representative: -
Last updated: 13.07.2026 21:16

Manufacturer products View details

NoFact VIII

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: r2 Diagnostics Inc.
Manufacturer SRN: US-MF-000020735
UDI-DI: 10859394006153
Basic UDI-DI: B-10859394006153
Reference: 68-201
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 11.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

Factor VIII Deficient Plasma

IVD generalIVDDNo longer on the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100048802
Basic UDI-DI: B-07798100048802
Reference: 1705017
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
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

BIOPHEN™ FVIII variant

Factor VIII (FVIII) bovine

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537084676
Basic UDI-DI: 366353700097BW
Reference: 227102
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 13:30

Manufacturer products View details

sthemO VIII

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

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 13607450012252
Basic UDI-DI: 3607450FACT0016DL
Reference: 01225
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:59

Manufacturer products View details

STA® - ImmunoDef VIII

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

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 13607450007289
Basic UDI-DI: 3607450FACT0006DH
Reference: 00728
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:59

Manufacturer products View details

STA® - Deficient VIII

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

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 13607450007258
Basic UDI-DI: 3607450FACT0005DF
Reference: 00725
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:59

Manufacturer products View details

HemosIL Factor VIII deficient plasma

0020012800

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950580690
Basic UDI-DI: 84269505806909C
Reference: 0020012800
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Factor VIII deficient plasma

0020011800

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950478560
Basic UDI-DI: 84269504785609W
Reference: 0020011800
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details

Factor VIII Chromogenic Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768004032
Basic UDI-DI: 0405686900866W9
Reference: 10445729
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 04:40

Manufacturer products View details

Coagulation Factor VIII Deficient Plasma

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640761
Basic UDI-DI: 0405686900159V9
Reference: 10873880
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:50

Manufacturer products View details