- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 13, 2026
B-15060527730349PATHTROL™ CONNECTIVE 2 CONTROL is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Eurobio Scientific UK Ltd. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
15060527730349PW882601(01)15060527730349
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152011CONTROLS FOR AUTOIMMUNITY4 warnings recorded — scroll inside the panel to see all entries.
Contains human material. The control serum has been tested and found negative for HIV1/2 Ab and HCV Ab, and non- reactive for HBSAg, HBV-DNA, HCV-RNA, HIV-RNA and STS. However, as human source products they should be treated as potentially infectious and handled appropriately.
Refer to ”Materials Safety Data Sheet” for more detailed safety information.
PathTROL™ Connective 2 Control should not be used beyond the expiry date printed on the tube label and packaging. If there are any signs of microbial contamination or excessive turbidity in the sera, they should be discarded.
PathTROL™ Connective 2 Control should only be used when the tubes are intact. If the tubes are damaged the control serum should be discarded.
UK-MF-000053721Primary placement in Belgium; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Aug 24, 2020 | Still on market |
| France | Mar 22, 2021 | Still on market |
| Ireland | Nov 3, 2020 | Still on market |
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 →B-25060527730339On the marketPATHTROL™ CONNECTIVE 2 CONTROLB-25060527730346On the marketPATHTROL™ CONNECTIVE 2 CONTROLB-35060527730343On the marketPATHTROL™ RHEUMA CONTROLB-35060527730206On the marketPATHTROL™ RHEUMA CONTROLB-15060527730202On the marketPATHTROL™ RHEUMA CONTROLB-25060527730209On 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.