- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jan 4, 2023
B-05391521420312TriniCLOT aPTT HS 10 mL is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Tcoag ireland ltd. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IE-MF-000027371(01)05391521420312
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 France; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | May 5, 2010 | May 26, 2027 |
| Belgium | May 5, 2010 | May 26, 2027 |
| Germany | May 5, 2010 | May 26, 2027 |
| Denmark | May 5, 2010 | May 26, 2027 |
| Spain | May 5, 2010 | May 26, 2022 |
| Finland | May 5, 2010 | May 26, 2027 |
| Ireland | May 5, 2010 | May 26, 2027 |
| Netherlands | May 5, 2010 | May 26, 2027 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05391521420312Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-05391521420312T1203UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103020102ACTIVATED PARTIAL THROMBOPLASTIN TIMEPrimary 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.
B-05391521420534On the marketTriniCHROM Factor VIII:cB-05391521420565On the marketTriniCLOT Calcium Chloride 0.025MB-05391521420510On the marketTriniCLOT aPTT HS 3 mLB-05391521420329On the marketTriniCLOT APTT S 10MLB-05391521420299On the marketTriniCLOT aPTT S 5 mLB-05391521421760On 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.