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

XSYS0049 — IVDR Class B IVDR by Erba Lachema s.r.o.

MD Atlas
Erba Lachema s.r.o.

EUDAMED last updated this device on Apr 22, 2026

XSYS0049

8592156CCRE0036T6

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Erba Lachema s.r.o.
UDI-DI code: 08592156085328
Reference / catalog number: XSYS0049

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: Erba Lachema s.r.o.
SRN: CZ-MF-000024067
Manufacturer status: Active

Critical warnings

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

CW043
EUDAMED did not publish a description for this code.
CW044
EUDAMED did not publish a description for this code.
CW095
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW159
EUDAMED did not publish a description for this code.
CW422
EUDAMED did not publish a description for this code.
CW313
EUDAMED did not publish a description for this code.
CW306
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08592156085328
Basic UDI-DI: 8592156CCRE0036T6
Reference / catalog number: XSYS0049
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The kit is intended for in vitro photometric quantitative determination of iron in human serum and plasma on automatic systems ERBA XL. Intended for screening, monitoring and diagnosis of iron deficiency anemia, hemochromatosis. For professional use in clinical laboratory only.
Additional information URL: https://www.erba.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010216IRON (CC)

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

This device is not currently linked to any other device.

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.