Factor VIII immunads. Deficient Plasma

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH Austria EUDAMED

Ref 5154002Model Factor VIII immunads. Deficient Plasma, Factor VIII DP

EMDN W0103020207

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberB-09120036860384 Basic UDI-DI	Date15 Jul 2026Registered	StatusActive
European Union	CE/IVDD	NumberB-09120036860384 Basic UDI-DI	Date15 Jul 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Trade Name: Factor VIII DP
Device Name: Factor VIII immunads. Deficient Plasma
Model / Reference: Factor VIII immunads. Deficient Plasma, 5154002, Factor VIII DP

Primary DI / UDI-DI: 09120036860384
Basic UDI-DI: B-09120036860384, 912003686TC480000001Q4
EMDN Code: W0103020207 Coagulation factor viii

Device Class: Class IVD General
Class C
Market of Registration: Austria

Manufacturer details

EUDAMED SRN: AT-MF-000024115

Other devices from Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

Normal Human Control Plasma

Class C
Ceveron m4

Class A
Imidazole Buffer

Class A
APC Resistance Kit

IVD General
TECHNOZYM ADAMTS13 CONT Set

IVD General
Technozym ADAMTS13 Elisa

IVD General

See all devices from Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH →

Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Reagent
Professional Testing

Other properties (8)

Sterile: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (2)

EUDAMED 09120036860384|B-09120036860384 61 fields · synced 25 Oct 2026
EUDAMED 09120036860384|912003686TC480000001Q4 61 fields · synced 25 Oct 2026