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Ch Vision Reading Glasses Dio 3.5
EUDAMEDClass I (EU MDR)
Ref 40448760 (KCR21058H)Model KCR2105
Identity
- Trade Name
- CH VISION READING GLASSES DIO 3.5 EUDAMED
- Device Name
- CH VISION READING GLASSES EUDAMED
- Model / Reference
- KCR2105 EUDAMED40448760 (KCR21058H) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661075012571 EUDAMED
- Basic UDI-DI
- 3661075RGKCR210566 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 Vision Reading Glasses 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 | 3661075RGKCR210566 | Class I | Active |
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Manufacturer
- Manufacturer
- Polyflame Europe Sas
- EUDAMED SRN
- FR-MF-000042860
Sources (1)
- EUDAMED 23b788f9-ef9e-4608-886c-4f250916c32d 61 fields · synced Jun 18, 2026