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EUDAMED last updated this device on Jul 21, 2026
B-08437024427018halosperm G2 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Halotech DNA. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08437024427018HT-HSG2(01)08437024427018
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01019099CLINICAL CHEMISTRY REAGENTS - OTHER2 warnings recorded — scroll inside the panel to see all entries.
Care should be taken to avoid contact with skin or eyes, and to prevent inhalation. The acid solution (DA) contains Hydrochloric acid, and the lysis solution (LS) contains Dithiothreitol and ECOSURF EH-9. Work under air removal environment and follow the manufacturer’s Material Safety Data regarding safe handling.
Primary placement in Spain; available across 1 country total.
Placed on the market in Spain; per-country availability dates not published.
ES-MF-000001921Sterile
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 →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.