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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

Q0210030102 — Class I MDR by POLYFLAME EUROPE SAS

MD Atlas
POLYFLAME EUROPE SAS

EUDAMED last updated this device on May 10, 2026

Q0210030102

3661075KCR21039F9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: POLYFLAME EUROPE SAS
UDI-DI code: 03661075000608
Reference / catalog number: CHVISION READING GLASSES 2026 DIO.2.5-D24

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Manufacturer information

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

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.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: Q0210030102
UDI-DI code: 03661075000608
Basic UDI-DI: 3661075KCR21039F9
Reference / catalog number: CHVISION READING GLASSES 2026 DIO.2.5-D24
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

Related devices

CHVISION READING GLASSES 2026 DIO.2.03661075KCR25002FEOn the market CHVISION READING GLASSES 2026 DIO.2.03661075KCR25002FEOn the market CHVISION READING GLASSES 2026 DIO.2.03661075KCR24065FXOn the market CHVISION READING GLASSES 2026 DIO.2.03661075KCR24065FXOn the market CHVISION READING GLASSES 2026 DIO.2.0

3661075KCR24053FQ

On 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.