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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

PROLENS de nuit — Class IIa MDR by LABORATOIRE PRECILENS

MD Atlas
LABORATOIRE PRECILENS

EUDAMED last updated this device on May 4, 2026

PROLENS de nuit

3666486OrthokpresbytieGT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LABORATOIRE PRECILENS
UDI-DI code: 03666486000803
Reference / catalog number: PROLENS de nuit

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Manufacturer information

Organization name: LABORATOIRE PRECILENS
SRN: FR-MF-000000913
Manufacturer status: Active

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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.

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW254
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03666486000803
Basic UDI-DI: 3666486OrthokpresbytieGT
Reference / catalog number: PROLENS de nuit
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Lentille de contact d'orthokératologie pour la presbytie
Additional information URL: https://www.precilens.com/notices-lentilles.php
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02100499CONTACT LENSES - 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
Serial number
Software identification