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EUDAMED last updated this device on Jul 2, 2025
88000385CZSOLPMHURO PATH® Solution (GYN) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by CelltraZone Co., Ltd. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08800038500358AHGYNV100(01)08800038500358
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01030799HISTOLOGY / CYTOLOGY REAGENTS - OTHERKR-MF-000026492The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Romania; available across 1 country total.
Placed on the market in Romania; 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 →88000385CZCONM9On the marketHURO PATH® Lysis Solution (Hemolics)88000385CZHEMM2On the marketHURO PATH® Solution (Diluent)88000385CZDILLQOn the marketHURO PATH® Solution (GYN)-BULK88000385CZBULKN5On the marketHURO PATH® Solution (Non-GYN)88000385CZNONNYOn the marketHURO PATH® T88000385CZHUROQ9On 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.