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OPTICAL FRAMES WITH ULTEM material
EUDAMEDClass I (EU MDR)
Ref OPTICAL FRAMES WITH ULTEM material
Identity
- Device Name
- OPTICAL FRAMES WITH ULTEM material EUDAMED
- Model / Reference
- OPTICAL FRAMES WITH ULTEM material EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800244850053 EUDAMED
- Basic UDI-DI
- 880024485SFK00006HQ EUDAMED
- EMDN Code
- Q02100202 PLASTIC 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 ULTEM 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 | 880024485SFK00006HQ | 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 110dcf46-5f7b-4d88-86d9-2eabb0b3db25 61 fields · synced Jun 18, 2026