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Take Care Eyewear Romane Black - Diopter +3.5
EUDAMEDClass I (EU MDR)
Ref 40448781Model PR-P15802
Identity
- Trade Name
- TAKE CARE EYEWEAR ROMANE BLACK - DIOPTER +3.5 EUDAMED
- Device Name
- READING GLASSES EUDAMED
- Model / Reference
- PR-P15802 EUDAMED40448781 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661075013875 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 Black - 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 | 3661075RGPRP15802V9 | Class I | Active |
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Manufacturer
- Manufacturer
- Polyflame Europe Sas
- EUDAMED SRN
- FR-MF-000042860
Sources (1)
- EUDAMED 53681580-99be-45bb-b40b-25bb2046e3b4 61 fields · synced Jun 18, 2026