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EUDAMED last updated this device on Jun 27, 2026
89080153043B1301KPTRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by 3B BlackBio Dx Limited. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
089062139304813B1301/CIN-MF-000023698(01)08906213930481
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0106010103FACTOR V LEIDENPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
89080153043B1321KVOn the marketTRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit89080153043B1301KPOn the marketTRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit89080153043B1301KPOn the marketTRUPCR® FFPE Tissue DNA Extraction Kit8906213933B207FTXOn the marketTRUPCR® HLA B-27 Real-Time PCR Kit89080153043B247NMOn the marketTRUPCR® HLA B-27 Real-Time PCR Kit89080153043B247NMOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.