- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Sep 14, 2023
42555978FIXATIONDFQ Fix 10 % Buffered Neutral Formalin is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by biocyc Biotechnologie GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04255597800427FX-001-0250(01)04255597800427
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01030799HISTOLOGY / CYTOLOGY REAGENTS - OTHER10 warnings recorded — scroll inside the panel to see all entries.
OTHER
OTHER
OTHER
DE-MF-000031533The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
OTHER
OTHER
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; 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 →No certificate specifically references this device's Basic UDI-DI.
42555978DILUENTYEOn the marketQ Diluent for IHC42555978DILUENTYEOn the marketQ Diluent for IHC w/o Green42555978DILUENTYEOn the marketQ Fix 10% Buffered Neutral Formalin42555978FIXATIONDFOn the marketQ Fix 10% Buffered Neutral Formalin42555978FIXATIONDFOn the marketQ Fix 10% Buffered Neutral Formalin42555978FIXATIONDFOn the marketCertificate health across this manufacturer's portfolio.
HX 1108389-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →