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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

ML90723 — Class I MDR by Internacional Ventur S.A.

MD Atlas
Internacional Ventur S.A.

EUDAMED last updated this device on May 23, 2022

ML90723

843702233600907FQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Internacional Ventur S.A.
UDI-DI code: 08437022336398
Reference / catalog number: ML90723

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Manufacturer information

Organization name: Internacional Ventur S.A.
SRN: ES-MF-000000386
Manufacturer status: Active

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ML13206843702233600132EFOn the market ML13207843702233600132EFOn the market VE13207843702233600132EFOn the market ML13211843702233600132EFOn the market ML13212843702233600132EFOn the market

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: 08437022336398
Basic UDI-DI: 843702233600907FQ
Reference / catalog number: ML90723
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Cubetas preformadas, anatómicas que al seguir la forma de los dientes consiguen una adaptación idónea. Están realizadas de polietileno expandido de uso aprobado en alimentación. Facilita la aplicación de flúor en forma de gel para prevenir la aparición de las caries. El flúor aumenta la resistencia del esmalte de los dientes a los ácidos que producen las bacterias de la placa bacteriana, origen de las caries.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q019007BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
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.