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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

SteatoTest — IVDD — General IVDD by Biopredictive

MD Atlas
Biopredictive

EUDAMED last updated this device on Oct 29, 2022

SteatoTest

B-03760373060106

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biopredictive
UDI-DI code: 03760373060106
Reference / catalog number: SteatoTest

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Manufacturer information

Organization name: Biopredictive
SRN: FR-MF-000003886
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: SteatoTest
UDI-DI code: 03760373060106
Basic UDI-DI: B-03760373060106
Reference / catalog number: SteatoTest
Issuing entity: GS1

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: Le SteatoTest estime le grade de stéatose (dépots de triglycérides dans le foie) chez les sujets avec HCV, HBV, NAFLD et ALD.
Additional information URL: https://www.biopredictive.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05030599DEVICES FOR PATOLOGY TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.