- Role
- Country
- Date of registration
- Address
CZ-MF-000001424HistoMED - Prefilled container 1,5 ml / Formaldehyde stabilized, buffered 4%, 0,7 ml is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by MEDILAB ČR s.r.o.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 1, 2026
85955947HISTOMEDW3Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08595594703779
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
12 warnings recorded — scroll inside the panel to see all entries.
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.
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.
Primary placement in Czechia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08595594703779Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
85955947HISTOMEDW3HMED05UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
1 packaging level registered — each level carries its own UDI-DI.
08595594703779× 1,000 unitsBase unit08595594705797× 1 unitEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)W05020199SAMPLES TRANSPORT, CONTAINERS - OTHER85955947JEDNORDEKYWFOn the marketDisposable Blanket 190 x 110 cm, 500 g, blue85955947JEDNORDEKYWFOn the marketDisposable Pillow 40 x 40 cm, white85955947JEDNORPOLABOn the marketHistoMED - Prefilled container 1000 ml / Formaldehyde stabilized, buffered 4%, 500 ml85955947HISTOMEDW3On the marketHistoMED - Prefilled container 120 ml / Formaldehyde stabilized, buffered 4%, 60 ml85955947HISTOMEDW3On the marketHistoMED - Prefilled container 14 ml / Formaldehyde stabilized, buffered 4%, 7 ml85955947HISTOMEDW3On 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.