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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

LV3917 — IVDD — General IVDD by SISTEMAS GENOMICOS. S.L.

MD Atlas
SISTEMAS GENOMICOS. S.L.

EUDAMED last updated this device on Dec 21, 2022

LV3917

B-08436566761352

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: SISTEMAS GENOMICOS. S.L.
UDI-DI code: 08436566761352
Reference / catalog number: LV3917

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Manufacturer information

Organization name: SISTEMAS GENOMICOS. S.L.
SRN: ES-MF-000022949
Manufacturer status: Active

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Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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: not provided
UDI-DI code: 08436566761352
Basic UDI-DI: B-08436566761352
Reference / catalog number: LV3917
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: Kit para ensayos diagnóstico de mutaciones germinales/somáticas en genes relacionados con Leucemia Mieloide Aguda, Síndromes Mielodisplásicos y Trastornos Mieloproliferativos Crónicos. Estudio de mutaciones puntuales, indels, large indels, ALUs y screening de CNVs.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W010699GENETIC TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

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.