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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

GALINET HAUTE VISION — Class I MDR by LM-HOLD

MD Atlas
LM-HOLD

EUDAMED last updated this device on Feb 7, 2024

GALINET HAUTE VISION

376040683HV3035W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LM-HOLD
UDI-DI code: 03760406830003
Reference / catalog number: 303

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Manufacturer information

Organization name: LM-HOLD
SRN: FR-MF-000039403
Manufacturer status: Active

Related devices

GALINET BASSE VISION376040683BV3023SOn the market GALINET VISION DE PRES376040683VP3019AOn the market LA GALINET376040683LOT3013023037BOn 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.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: GALINET HAUTE VISION
UDI-DI code: 03760406830003
Basic UDI-DI: 376040683HV3035W
Reference / catalog number: 303
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: échelle d'acuité visuelle
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER

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
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Software identification