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

MALDI Biotyper sirius IVD System — IVDR Class A IVDR

MD Atlas
Bruker Daltonics GmbH & Co. KG

EUDAMED last updated this device on Jan 15, 2026

MALDI Biotyper sirius IVD System

425120430100001001EH

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Bruker Daltonics GmbH & Co. KG
UDI-DI code: 04251204326120
Reference / catalog number: 1890112

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: Bruker Daltonics GmbH & Co. KG
SRN: DE-MF-000024392
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW013
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW008
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: MALDI Biotyper sirius IVD System
UDI-DI code: 04251204326120
Basic UDI-DI: 425120430100001001EH
Reference / catalog number: 1890112
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W020303MASS - SPECTROMETRY SYSTEM

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

MALDI Biotyper sirius one IVD System425120430100001002EKOn the market MALDI Biotyper-BD sirius IVD System425120430100001003EMOn the market MALDI Biotyper-BD sirius one IVD System425120430100001004EPOn the market MBT Biotarget 96 IVD425120430100001000EFOn the market MBT Target polished steel 96 IVD425120430100001023ETOn 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.