Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

LV3658 — IVDD — General IVDD by SISTEMAS GENOMICOS. S.L.

MD Atlas
SISTEMAS GENOMICOS. S.L.

EUDAMED last updated this device on Dec 21, 2022

LV3658

B-08436566760782

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: 08436566760782
Reference / catalog number: LV3658

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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: 08436566760782
Basic UDI-DI: B-08436566760782
Reference / catalog number: LV3658
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 en genes relacionados con cáncer hereditario de orígen heterogéneo. 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
Serial number
Software identification

Related devices

LV4615B-08436566763165On the market LV3891B-08436566761420On the market LV3454B-08436566761024On the market LV3455B-08436566761031On the market LV3461B-08436566761055On 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.