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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

Optotipo Retroiluminado 5M — Class I MDR by General ASDE, S.A.

MD Atlas
General ASDE, S.A.

EUDAMED last updated this device on May 21, 2024

Optotipo Retroiluminado 5M

8437024525opto_VLBD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: General ASDE, S.A.
UDI-DI code: 08437024525028
Reference / catalog number: Optotipo Retroiluminado 5M

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Manufacturer information

Organization name: General ASDE, S.A.
SRN: ES-MF-000014654
Manufacturer status: Active

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: 08437024525028
Basic UDI-DI: 8437024525opto_VLBD
Reference / catalog number: Optotipo Retroiluminado 5M
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: El Optotipo 5M es un producto diseñado para la realización de la prueba “Agudeza visual a distancia” dentro de la exploración oftalmológica establecida en el Protocolo de Exploración para conductores y tenencia de armas.
Additional information URL: http://www.optotipo.es/
Clinical sizes: Distancia — 2.5–5 MU36

EMDN nomenclature code(s)

Z12120115OPTOMETERS

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

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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.