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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

Théraflux — IVDD — General IVDD by THERADIAL

MD Atlas
THERADIAL

EUDAMED last updated this device on Nov 13, 2025

Théraflux

B-TFX101GY

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: THERADIAL
UDI-DI code: D-TFX101GY
Reference / catalog number: TFX101

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Manufacturer information

Organization name: THERADIAL
SRN: FR-MF-000011764
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 26, 2018	May 27, 2027

Device identification

Trade name: Théraflux
UDI-DI code: D-TFX101GY
Basic UDI-DI: B-TFX101GY
Reference / catalog number: TFX101
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: Dialysate Sampler
Additional information URL: https://theradial.com/nos-solutions/nos-dispositifs-medicaux/theraflux/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02060102AUTOMATED SAMPLE TRANSPORT SYSTEMS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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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.