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Take Care Eyewear Alexi - Diopter +3.5
EUDAMEDClass I (EU MDR)
Ref 40448841 (PR-M12181A)Model PR-M12
Identity
- Trade Name
- TAKE CARE EYEWEAR ALEXI - DIOPTER +3.5 EUDAMED
- Device Name
- TAKE CARE EYEWEAR - READING GLASSES EUDAMED
- Model / Reference
- PR-M12 EUDAMED40448841 (PR-M12181A) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661075014872 EUDAMED
- Basic UDI-DI
- 3661075RGPRM12Z8 EUDAMED
- EMDN Code
- Q0210030101 READY TO WEAR METAL SPECTACLES WITH ORGANIC LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Take Care Eyewear Alexi - Diopter +3.5 by Polyflame Europe Sas — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661075RGPRM12Z8 | Class I | Active |
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Manufacturer
- Manufacturer
- Polyflame Europe Sas
- EUDAMED SRN
- FR-MF-000042860
Sources (1)
- EUDAMED 320996a1-91e5-4267-a7b2-7840d6ccd0d4 61 fields · synced Jun 19, 2026