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

83101 — IVDR Class A IVDR by BIOSYSTEMS S.A.

MD Atlas
BIOSYSTEMS S.A.

EUDAMED last updated this device on Oct 29, 2025

83101

8435287191A2500000007R

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BIOSYSTEMS S.A.
UDI-DI code: 08435287108101
Reference / catalog number: 83101

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

Related devices

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

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 25, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435287108101
Basic UDI-DI: 8435287191A2500000007R
Reference / catalog number: 83101
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: See IFU
Additional information URL: https://biosystems.global/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201010101CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

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