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

12540 — IVDD — General IVDD by BIOSYSTEMS S.A.

MD Atlas
BIOSYSTEMS S.A.

EUDAMED last updated this device on Oct 22, 2025

12540

B-08435287111774

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOSYSTEMS S.A.
UDI-DI code: 08435287111774
Reference / catalog number: 12540

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: BIOSYSTEMS S.A.
SRN: ES-MF-000000231
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Mar 9, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435287111774
Basic UDI-DI: B-08435287111774
Reference / catalog number: 12540
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: See IFU (section intended use)
Additional information URL: https://einfo.bio/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010222NON ESTERIFIED FATTY ACIDS

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

Certificates

Certificate health across this manufacturer's portfolio.

HX 1695779-1Supplemented
Quality management systemNotified body: 0197Expiry: Feb 24, 2030

Related devices

31100B-08435287111002On the market 31107B-08435287111071On the market 22340B-08435287112023On the market 31014B-08435287110142On the market 31086B-08435287110869On the market