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OPTICAL FRAMES WITH TITANIUM material
EUDAMEDClass I (EU MDR)
Ref OPTICAL FRAMES WITH TITANIUM material
Identity
- Device Name
- OPTICAL FRAMES WITH TITANIUM material EUDAMED
- Model / Reference
- OPTICAL FRAMES WITH TITANIUM material EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800244850060 EUDAMED
- Basic UDI-DI
- 880024485SFK00007HS EUDAMED
- EMDN Code
- Q02100201 METAL SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
OPTICAL FRAMES WITH TITANIUM material by Jungsun Optical Co. — 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 | 880024485SFK00007HS | Class I | Active |
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Manufacturer
- Manufacturer
- Jungsun Optical Co.
- EUDAMED SRN
- KR-MF-000039347
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 77892863-9e21-4588-93f6-16e0be693031 61 fields · synced Sep 18, 2026