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IT-MF-000027944EEG HEADCAP BASIS BE - 32+2 Ag/AgCl Cylindrical Electrodes Size 5 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by EB Neuro S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Oct 24, 2024
080564469AccessoriEEG_KNPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08056446907078
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Italy; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Poland | — | Still on market |
| Romania | — | 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.
08056446907078Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
080564469AccessoriEEG_KNB9603094015UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
N01010203EEG HEADSETS080564469ElettrEAR_LSOn the marketEar Electrode Tin - cable 100cm FMM 1,5mm080564469ElettrEAR_LSOn the marketEEG BE PLUS LTM / BE PLUS PRO 21 Ag/AgCl Cylindrical Electrodes+A1+A2 Size 2080564469AccessoriEEG_KNOn the marketEEG Headcap BE LIGHT 10 Ag/AgCl Electrodes - Size 2080564469AccessoriEEG_KNOn the marketEEG Headcap BE LIGHT 10 Ag/AgCl Electrodes - Size 3080564469AccessoriEEG_KNOn the marketEEG Headcap BE LIGHT 21 Ag/AgCl Cylindrical Electrodes - Size 3080564469AccessoriEEG_KNOn 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.