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EUDAMED last updated this device on Aug 5, 2024
B-06438172401129NeoMass CAH System Suitability Mixture (lyophilized) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Labsystems Diagnostics Oy. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
064381724011293467709FI-MF-000018281(01)06438172401129
5 warnings recorded — scroll inside the panel to see all entries.
may cause damage to organs
May cause cancer
May cause fertility issues in unborn child
May cause damage in fertility
May cause harm to breast fed child
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 Finland; available across 1 country total.
Placed on the market in Finland; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152202HORMONE STANDARDS AND CALIBRATORSPrimary 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.
B-06438172401037On the marketNeoMass CAH Reconstitution SolutionB-06438172401051On the marketNeoMass CAH Rinsing SolutionB-06438172401082On the marketNeoMass CAH Tuning Mixture (lyophilized)B-06438172401112On the marketNeoNat SCID Real-Time PCR KitB-06438172309029On the marketNeoNat SCID Real-Time PCR KitB-06438172309012On 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.