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Ch Reading Glasses W/Handtag Dio2.0
EUDAMEDClass I (EU MDR)
Ref 40448751Model PR-P15104Model PR-P15347F 1PCModel PR-P15398Model PR-P15300Model PR-P15250
Identity
- Trade Name
- CH READING GLASSES W/HANDTAG DIO2.0 EUDAMED
- Device Name
- READING GLASSES EUDAMED
- Model / Reference
- PR-P15104 EUDAMED40448751 EUDAMEDPR-P15347F 1PC EUDAMEDPR-P15398 EUDAMEDPR-P15300 EUDAMEDPR-P15250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661075010843 EUDAMED03661075010348 EUDAMED03661075011048 EUDAMED03661075010447 EUDAMED03661075011147 EUDAMED03661075010249 EUDAMED03661075010140 EUDAMED03661075011246 EUDAMED03661075010744 EUDAMED
- Basic UDI-DI
- 3661075RGPRP15104UA EUDAMED3661075RGPRP15347V6 EUDAMED3661075RGPRP15398VP EUDAMED3661075RGPRP15300UC EUDAMED3661075RGPRP15250UN 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 Dio2.0 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 | 3661075RGPRP15104UA | Class I | Active |
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Manufacturer
- Manufacturer
- Polyflame Europe Sas
- EUDAMED SRN
- FR-MF-000042860
Sources (9)
- EUDAMED 0be3c213-8411-4513-9d63-7226b9b25fe0 61 fields · synced Jul 25, 2026
- EUDAMED c68dc450-3e12-46ee-9dce-91344bed36ef 61 fields · synced May 16, 2026
- EUDAMED 9138daf8-5aff-4b53-aa0a-692deb963289 61 fields · synced May 17, 2026
- EUDAMED 3e087b55-843b-40bd-88e4-24c323c23429 61 fields · synced May 17, 2026
- EUDAMED c49b2fee-4f18-4d75-aa7c-9d6e86914b69 61 fields · synced May 18, 2026
- EUDAMED acfa8ba3-97a8-4b18-aa38-a59443675efb 61 fields · synced May 18, 2026
- EUDAMED 7b514a0b-d34d-4819-8152-77e03ae0efee 61 fields · synced May 19, 2026
- EUDAMED 9a2d3ec7-840e-450e-8960-3f15154a6312 61 fields · synced May 19, 2026
- EUDAMED 510f0606-b7ec-4965-bfed-673460bdf62a 61 fields · synced May 19, 2026