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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

EKA0005UU — IVDD — General IVDD by ILINE MICROSYSTEMS S.L.

MD Atlas
ILINE MICROSYSTEMS S.L.

EUDAMED last updated this device on Jan 23, 2026

EKA0005UU

B-08436540290083

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ILINE MICROSYSTEMS S.L.
UDI-DI code: 08436540290083
Reference / catalog number: EKA0005UU

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Manufacturer information

Organization name: ILINE MICROSYSTEMS S.L.
SRN: ES-MF-000013573
Manufacturer status: Active

Related devices

CHB0025AB-10B-08436540291189On the market CHB0025ACB-08436540290359On the market CHB0025AAB-08436540290335On the market CHB0025ABB-08436540290342On the market CHB0025AUB-08436540290687On the market

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

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW008
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Sweden; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08436540290083
Basic UDI-DI: B-08436540290083
Reference / catalog number: EKA0005UU
Issuing entity: GS1

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: Quality control solution for the microINR® system.
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

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Expiration date
Manufacturing date
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Software identification