EUDAMED last updated this device on Feb 18, 2025

NEOSICKLE NS540_BR

3770024008NEOSICKLEBW

On the marketIVDR Class C

Applicable legislation: —
Organization name: BIOMANEO
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 03770024008005
Reference / catalog number: S227-49502-55

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

NEOSICKLE NS540_BR is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by BIOMANEO. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: NEOSICKLE NS540_BR
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 03770024008005
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 3770024008NEOSICKLEBW
Reference / catalog number: S227-49502-55
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The device NeoSickle is an in vitro diagnostic medical device intended for the screening by mass spectrometry of major sickle cell syndrome or sickle cell trait, by detecting the presence of the "S" mutated beta haemoglobin (Hb) chain and/or the absence of the "A" non-mutated beta haemoglobin chain from dried blood samples. This device includes the software eNeoSickle. The variant NeoSickle NS540 is for high-throughput automated sickle cell screening.
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

UDI-DI DataMatrix

Encoded

(01)03770024008005

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

W0103010299OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	—	Still on market

NEOSICKLE NS540_BR

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

Related devices

Certificates