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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

E105 — Class I MDR by GIUNTA ERASMO s.a.s. di…

MD Atlas
GIUNTA ERASMO s.a.s. di Ing. Giovanni Giunta & C.

EUDAMED last updated this device on Jun 30, 2025

E105

805600049E105Z4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GIUNTA ERASMO s.a.s. di Ing. Giovanni Giunta & C.
UDI-DI code: 08056000490114
Reference / catalog number: E105

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Manufacturer information

Organization name: GIUNTA ERASMO s.a.s. di Ing. Giovanni Giunta & C.
SRN: IT-MF-000030841
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW011
Gli elettrodi che perdono la depolarizzazione possono risultare instabili, cioè produrre artefatti sul tracciato. Questo prodotto è fabbricato esclusivamente per essere usato solamente come elettrodo per Elettroencefalografia. Non utilizzare dopo la data di scadenza evidenziata sulla confezione (5 anni).
CW032
5 anni

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08056000490114
Basic UDI-DI: 805600049E105Z4
Reference / catalog number: E105
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 10
Additional product description: Elettrodo unipolare a tampone per EEG taglia adulti con foro per spina diametro 2,5 mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

N01010299EEG ELECTRODES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

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.

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