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Ch Reading Glasses W/Handtag Dio3.5
EUDAMEDClass I (EU MDR)
Ref 40448754Model PR-P15802Model PR-P15250Model PR-P15300Model PR-P15347F 1PCModel PR-P15398
Identity
- Trade Name
- CH READING GLASSES W/HANDTAG DIO3.5 EUDAMED
- Device Name
- READING GLASSES EUDAMED
- Model / Reference
- PR-P15802 EUDAMED40448754 EUDAMEDPR-P15250 EUDAMEDPR-P15300 EUDAMEDPR-P15347F 1PC EUDAMEDPR-P15398 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661075010676 EUDAMED03661075010171 EUDAMED03661075010577 EUDAMED03661075011178 EUDAMED03661075010379 EUDAMED03661075011079 EUDAMED03661075010478 EUDAMED
- Basic UDI-DI
- 3661075RGPRP15802V9 EUDAMED3661075RGPRP15250UN EUDAMED3661075RGPRP15300UC EUDAMED3661075RGPRP15347V6 EUDAMED3661075RGPRP15398VP 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
Ch Reading Glasses W/Handtag Dio3.5 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 (7)
- EUDAMED 487423ff-18c5-407a-b48f-1751cc6baeef 61 fields · synced Sep 18, 2026
- EUDAMED e1c7b2a3-e006-48c6-80b5-32958a4fa4a3 61 fields · synced May 16, 2026
- EUDAMED 939c9815-9696-44fe-9288-d12eeafef565 61 fields · synced May 17, 2026
- EUDAMED 8e0bee45-611c-46d2-a022-43e4d1dfd4b3 61 fields · synced May 17, 2026
- EUDAMED 5b334333-617e-4f4e-a56f-e03ffb828e8d 61 fields · synced May 17, 2026
- EUDAMED 672a151d-6b70-409c-9ea7-79031d6b6827 61 fields · synced May 17, 2026
- EUDAMED f594e6ef-19c9-4325-a02a-088206e3f8f8 61 fields · synced May 18, 2026