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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

Neuronaute® IceCap 2 — Class I MDR by BIOSERENITY MEDICAL…

MD Atlas
BIOSERENITY MEDICAL DEVICES GROUP

EUDAMED last updated this device on Oct 1, 2025

Neuronaute® IceCap 2

361522WEMUelectrodsFY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSERENITY MEDICAL DEVICES GROUP
UDI-DI code: 03615220004331
Reference / catalog number: 1001-01025-UN

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Manufacturer information

Organization name: BIOSERENITY MEDICAL DEVICES GROUP
SRN: FR-MF-000039391
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW027
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Sep 29, 2025	Still on market
Belgium	Sep 29, 2025	Still on market

Device identification

Trade name: Neuronaute® IceCap 2
UDI-DI code: 03615220004331
Basic UDI-DI: 361522WEMUelectrodsFY
Reference / catalog number: 1001-01025-UN
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: —
Additional information URL: https://bioserenity.com/quality-europe/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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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.