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EUDAMED last updated this device on Mar 25, 2025
3661075DIOPTERWMCH VISION READING GLASSES DIO1.5 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by POLYFLAME EUROPE SAS. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0366107501143740448756 (KC742120B)(01)03661075011437
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0210030102READY TO WEAR PLASTIC SPECTACLES WITH ORGANIC LENSES1 warning recorded — scroll inside the panel to see all entries.
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.
FR-MF-000042860The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in France; available across 1 country total.
Placed on the market in France; per-country availability dates not published.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →3661075RGKC9906SVOn the marketCH VISION READING GLASSES DIO 3.53661075RGKC9906SVOn the marketCH VISION READING GLASSES DIO 3.53661075RGKC9906SVOn the marketCHAMP HEALTH - DINO BAND AIDS BLIST.10 P3661075JDAB009F3On the marketCHVISION READING GLASSES 2026 DIO.2.53661075KCR24020F9On the marketCHVISION READING GLASSES 2026 DIO.2.53661075KCR25002FEOn the marketNo certificate specifically references this device's Basic UDI-DI.
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.