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EUDAMED last updated this device on Nov 23, 2023
5904365620KOLBLAB Group Serum is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05904365620239663(01)05904365620239
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103030306ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)1 warning recorded — scroll inside the panel to see all entries.
Avoid skin and mucous membranes contact. Biological material with negative test results for HIV, HBV, HCV and syphilis was used for reagent manufacturing (human plasma) but exercise care using the reagent, removing post-reaction mixture and used packages. Do not pipette by mouth.
PL-MF-000037642The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
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.
View in glossary →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.
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 →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 →5904365620MEH4On the marketAnti-IgG reagentB-05904365620222On the marketCoated Standardized Red Blood Cells ORhD+ with anti-D antibodiesB-05904365620109On the marketCoated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USEB-05904365620116On the marketNo 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.