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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

CK-NAC/CK-MB Control (level 1), 1… — IVDD — General IVDD

MD Atlas
Chronolab Systems, S.L.

EUDAMED last updated this device on Oct 15, 2025

CK-NAC/CK-MB Control (level 1), 1 x 2 mL

B-084360388478473KB

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-084360388478473KB
Reference / catalog number: 101-0697

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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
The individual units comprising lot or lots of components from human origin, have been tested for HBsAg and antibodies to HIV and found negative / non reactive by an FDA approved test. 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: CK-NAC/CK-MB Control (level 1), 1 x 2 mL
UDI-DI code: D-084360388478473KB
Basic UDI-DI: B-084360388478473KB
Reference / catalog number: 101-0697
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 (human serum) Reconstitution of reagent 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)

W0101050201ENZYME CONTROLS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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