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OPTICAL FRAMES WITH METAL material
EUDAMEDClass I (EU MDR)
Ref OPTICAL FRAMES WITH METAL materialRef OPTICAL FRAMES
Identity
- Trade Name
- OPTICAL FRAMES EUDAMED
- Device Name
- OPTICAL FRAMES WITH METAL material EUDAMEDOPTICAL FRAMES EUDAMED
- Model / Reference
- OPTICAL FRAMES WITH METAL material EUDAMEDOPTICAL FRAMES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800244850039 EUDAMED18800244850008 EUDAMED
- Basic UDI-DI
- 880024485SFK00004HL EUDAMED880024485SFK00001HE EUDAMED
- EMDN Code
- Q02100201 METAL SPECTACLE FRAMES WITHOUT LENSES EUDAMEDQ02100203 METAL AND 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 METAL 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 | 880024485SFK00004HL | 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 (2)
- EUDAMED 34c51d71-0927-4346-849e-8a8a1683718b 61 fields · synced Jul 12, 2026
- EUDAMED 47aa9ac0-3a5f-4621-858c-17a2142b7de5 61 fields · synced May 19, 2026