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ENT Endoscopy Visual System
EUDAMEDClass I (EU MDR)
Ref ENT Endoscopy Visual System / MGSI-CA-ENT UNITModel NET-260SLCBRef ENT Endoscopy Visual System / MGSI-CA-260SLCBModel NET-260SLCB, NET-260SLCB(HD), NET-260SLCB FHD, LS-PT
Identity
- Trade Name
- ENT Endoscopy Visual System EUDAMED
- Device Name
- Light Source for endoscope EUDAMEDENT Endoscopy Visual System EUDAMED
- Model / Reference
- NET-260SLCB EUDAMEDENT Endoscopy Visual System / MGSI-CA-ENT UNIT EUDAMEDNET-260SLCB, NET-260SLCB(HD), NET-260SLCB FHD, LS-PT EUDAMEDENT Endoscopy Visual System / MGSI-CA-260SLCB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800029902502 EUDAMED
- Basic UDI-DI
- B-18800029902502 EUDAMED88000299GTVS10PP EUDAMED
- Direct Marketing DI
- 18800029902502 EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
ENT Endoscopy Visual System by Mega Medical Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-18800029902502 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-18800029902502 | Class I | Active |
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Manufacturer
- Manufacturer
- Mega Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000008718
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED f16c00a2-8eb6-41fa-a56f-36d99b15661c 61 fields · synced Jun 18, 2026
- EUDAMED fab85170-b73d-42e7-9577-f24c74cebf32 61 fields · synced Jun 18, 2026