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

Bilirubin Direct, 8 x 100 mL — IVDD — General IVDD

MD Atlas
Chronolab Systems, S.L.

EUDAMED last updated this device on Oct 9, 2025

Bilirubin Direct, 8 x 100 mL

B-084360387877871LP

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Chronolab Systems, S.L.
UDI-DI code: D-084360387877871LP
Reference / catalog number: 101-0598

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: Chronolab Systems, S.L.
SRN: ES-MF-000017043
Manufacturer status: Active

Related devices

Acid phosphatase, 18 x 2 mLB-084360386006008CTOn the market Acid phosphatase, 4 x 50 mLB-084360388038031F7On the market Agglutination slide and tube tests with positive and negative controls, 8 x 5 mL, 2 x 1 mLB-084360386316313EMOn the market Albumin, 3 x 100 mLB-084360385725728GVOn the market Albumin, 4 x 250 mLB-084360385395393HDOn the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
R1: H314-Causes severe burns and eye damage. EUH208-Contains sulphanilic acid (C6H7NO3S). May produce an allergic reaction. Follow the precautionary statements given in MSDS and label of the product.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: Bilirubin Direct, 8 x 100 mL
UDI-DI code: D-084360387877871LP
Basic UDI-DI: B-084360387877871LP
Reference / catalog number: 101-0598
Issuing entity: EUDAMED

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: Kit content: Reagent 1 (Sulfanilic acid), Reagent 2 (Sodium nitrite) All the reagents are ready to use. Additional equipment needed: Standard laboratory equipment.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010203BILIRUBIN

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

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.