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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

TF01-IT — Class I MDR by Incereb Ltd

MD Atlas
Incereb Ltd

EUDAMED last updated this device on Jul 7, 2024

TF01-IT

539153095TF01KAF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Incereb Ltd
UDI-DI code: 05391530950152
Reference / catalog number: TF01-IT

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Manufacturer information

Organization name: Incereb Ltd
SRN: IE-MF-000002463
Manufacturer status: Active

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: 05391530950152
Basic UDI-DI: 539153095TF01KAF
Reference / catalog number: TF01-IT
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: 1
Additional product description: Italian language labelling of English TF01
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N01010202EEG EXTRACRANIC ELECTRODES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Neon12539153095TF01KAFOn the market TF04-IT539153095TF04KAQOn the market Neon8539153095TF04KAQOn the market

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.