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Take Care Eyewear Romane Tortoiseshell- Dio +3.5
EUDAMEDClass I (EU MDR)
Ref 40448775 (PR-P15802)Model PR-P15802
Identity
- Trade Name
- TAKE CARE EYEWEAR ROMANE TORTOISESHELL- DIO +3.5 EUDAMED
- Device Name
- READING GLASSES EUDAMED
- Model / Reference
- PR-P15802 EUDAMED40448775 (PR-P15802) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661075013776 EUDAMED
- Basic UDI-DI
- 3661075RGPRP15802V9 EUDAMED
- EMDN Code
- Q0210030102 READY TO WEAR PLASTIC 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 Romane Tortoiseshell- Dio +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 | 3661075RGPRP15802V9 | Class I | Active |
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Manufacturer
- Manufacturer
- Polyflame Europe Sas
- EUDAMED SRN
- FR-MF-000042860
Sources (1)
- EUDAMED 7dc7587e-198f-4494-91a8-21cc9d64963c 61 fields · synced Jul 15, 2026