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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

RadioDtect — IVDD — General IVDD by NEOLYS Diagnostics

MD Atlas
NEOLYS Diagnostics

EUDAMED last updated this device on Apr 16, 2026

RadioDtect

B-RadioDtect4Z

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: NEOLYS Diagnostics
UDI-DI code: D-RadioDtect4Z
Reference / catalog number: RadioDtect

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Manufacturer information

Organization name: NEOLYS Diagnostics
SRN: FR-MF-000036165
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-RadioDtect4Z
Basic UDI-DI: B-RadioDtect4Z
Reference / catalog number: RadioDtect
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102019099SPECIFIC PROTEINS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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Manufacturing date
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Software identification

Related devices

This device is not currently linked to any other device.

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.