Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

SteatoTest2 — IVDD — General IVDD by Biopredictive

MD Atlas
Biopredictive

EUDAMED last updated this device on Oct 29, 2022

SteatoTest2

B-03760373060045

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biopredictive
UDI-DI code: 03760373060045
Reference / catalog number: SteatoTest2

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: SteatoTest2
UDI-DI code: 03760373060045
Basic UDI-DI: B-03760373060045
Reference / catalog number: SteatoTest2
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: Test diagnostique de la stéatose hépatique seconde génération
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

Related devices

AshTestB-03760373060052On the market FibroMaxB-03760373060021On the market FibroTestB-03760373060007On the market FibroTest NB-03760373060113On the market FibroTest-ActiTestB-03760373060137On the market

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.