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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

Coagulation control N, 4 x 1 mL — IVDD — General IVDD

MD Atlas
Chronolab Systems, S.L.

EUDAMED last updated this device on Oct 15, 2025

Coagulation control N, 4 x 1 mL

B-084360388688682LT

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-084360388688682LT
Reference / catalog number: 104-0022

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Manufacturer information

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

Critical warnings

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

CW008
Each unit of source material used in the preparation of this product has been tested by an FDA licensed method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. However, as no known test method can offer complete assurance that products derived from human blood will not transmit infectious diseases, this product must be handled as potencially infectious biological material.

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: Coagulation control N, 4 x 1 mL
UDI-DI code: D-084360388688682LT
Basic UDI-DI: B-084360388688682LT
Reference / catalog number: 104-0022
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 plasma) 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)

W0103020702CONTROL PLASMA FOR HAEMOSTASIS

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

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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.