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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

HbA1c, R1 1 x 30 mL, R2 1 x 10… — IVDD — General IVDD

MD Atlas
Chronolab Systems, S.L.

EUDAMED last updated this device on Oct 14, 2025

HbA1c, R1 1 x 30 mL, R2 1 x 10 mL, R3 1 x 125 mL

B-084360388858853LP

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-084360388858853LP
Reference / catalog number: 101-0771

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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
All human specimens should be regarded as potentially biohazardous. Therefore, universal precautions should be used in specimen handling (gloves, lab garments, avoid aerosol production, etc.).

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: HbA1c, R1 1 x 30 mL, R2 1 x 10 mL, R3 1 x 125 mL
UDI-DI code: D-084360388858853LP
Basic UDI-DI: B-084360388858853LP
Reference / catalog number: 101-0771
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 (Latex), Reagent 2 (Antibody), Reagent 3 (Hemolysis reagent) 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)

W01010214GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification