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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

TAKE CARE EYEWEAR ROMANE BLACK -… — Class I MDR

MD Atlas
POLYFLAME EUROPE SAS

EUDAMED last updated this device on Jun 18, 2025

TAKE CARE EYEWEAR ROMANE BLACK - DIOPTER +2.0

3661075RGPRP15802V9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: POLYFLAME EUROPE SAS
UDI-DI code: 03661075013844
Reference / catalog number: 40448778 (PR-P15802-9)

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Manufacturer information

Organization name: POLYFLAME EUROPE SAS
SRN: FR-MF-000042860
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
FOR CLOSE-UP VIEWING AND READING ONLY. ONLY AN OPHTHALMOLOGIST CAN DETERMINE YOUR VISION CORRECTION NEEDS AND THE HEALTH OF YOUR EYES. DO NOT USE FOR DRIVING OR OPERATING ANY OTHER TYPE OF VEHICLE. DO NOT USE FOR DISTANCE VISION. DO NOT USE AS EYE PROTECTION.

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: TAKE CARE EYEWEAR ROMANE BLACK - DIOPTER +2.0
UDI-DI code: 03661075013844
Basic UDI-DI: 3661075RGPRP15802V9
Reference / catalog number: 40448778 (PR-P15802-9)
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0210030102READY TO WEAR PLASTIC SPECTACLES WITH ORGANIC LENSES

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.