- Role
- Country
- Date of registration
- Address
PL-MF-000037642LISS-M (low ionic strength solution medium) is a salt solution with low ionic strength, standardised pH and osmolality values. LISS-M reagent is used for washing and preparing red cell suspensions for in vitro immunohaematology tests. is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 8, 2024
5904365620LISSM99Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05904365620277
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 Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05904365620277Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5904365620LISSM99911UDI 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.
W0103030306ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)No certificate specifically references this device's Basic UDI-DI.
No 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.B-05904365620093On the marketDolichotestB-05904365620246On the marketLISS - L Low ionic strenght salt solution5904365620LISSL97On the marketPapain STB-05904365620147On the marketPBS – buffered salt solution pH 6,9 (5 liters)5904365620PBSBLOn the marketPBS buffered salt solution pH 6,9 (2liters)5904365620PBSBLOn the market