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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

LDL Cholesterol Direct, R1 1 x 30… — IVDD — General IVDD

MD Atlas
Chronolab Systems, S.L.

EUDAMED last updated this device on Oct 10, 2025

LDL Cholesterol Direct, R1 1 x 30 mL, R2 1 x 10 mL, Cal 1 x 1 mL

B-084360387317319FR

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-084360387317319FR
Reference / catalog number: 101-0535

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Manufacturer information

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

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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.

Critical warnings

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

CW008
HDLc/LDLc CAL: Components from human origin have been tested and found to be negative for the presence of HBsAg, HCV, and antibody to HIV (1/2). However handle cautiously as potentially infectious.

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: LDL Cholesterol Direct, R1 1 x 30 mL, R2 1 x 10 mL, Cal 1 x 1 mL
UDI-DI code: D-084360387317319FR
Basic UDI-DI: B-084360387317319FR
Reference / catalog number: 101-0535
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 (enzymes), Reagent 2 (enzymes), HDL/LDL calibrator (Lyophilized human serum) Working reagent must be prepared according to IFU. 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)

W01010221LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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