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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

Nelli — Class I MDD by Neuro Event Labs Oy

MD Atlas
Neuro Event Labs Oy

EUDAMED last updated this device on Nov 21, 2022

Nelli

B-FIMF000024833CR023335X2

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Neuro Event Labs Oy
UDI-DI code: D-FIMF000024833CR023335X2
Reference / catalog number: 61288

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Manufacturer information

Organization name: Neuro Event Labs Oy
SRN: FI-MF-000024833
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: Nelli
UDI-DI code: D-FIMF000024833CR023335X2
Basic UDI-DI: B-FIMF000024833CR023335X2
Reference / catalog number: 61288
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Nelli® allows users to analyze and quantify motion and sound activity that suggest seizure behavior in adults and children. Nelli® consists of software as a Medical Device and an accessory Personal Recording Unit (PRU). The PRU captures video and audio recordings of the patient either at home or in a healthcare facility. Software processes the recordings and registers motions and sounds that indicates a seizure. Users of software are healthcare professionals. PRU is used by device installers and patient caretakers.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z121002NERVOUS SYSTEM MONITORING SYSTEMS

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

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1233-860-24Supplemented
Quality management systemNotified body: 0537Expiry: Dec 20, 2029