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Light source for endoscope
EUDAMEDClass I (EU MDR)
Ref Portable Pen Light / MGSI-CA-ENT UNITModel LS-PTRef ENT Endoscopy Visual System / MGSI-CA-ENT UNITModel NET-260SLCB(HD)Ref Portable Pen Light / MGSI-CA-LS-PTModel NET-260SLCB, NET-260SLCB(HD), NET-260SLCB FHD, LS-PTRef ENT Endoscopy Visual System / MGSI-CA-VS
Identity
- Trade Name
- ENT Endoscopy Visual System EUDAMED
- Device Name
- Light source for endoscope EUDAMEDENT Endoscopy Visual System EUDAMED
- Model / Reference
- LS-PT EUDAMEDPortable Pen Light / MGSI-CA-ENT UNIT EUDAMEDNET-260SLCB(HD) EUDAMEDENT Endoscopy Visual System / MGSI-CA-ENT UNIT EUDAMEDNET-260SLCB, NET-260SLCB(HD), NET-260SLCB FHD, LS-PT EUDAMEDPortable Pen Light / MGSI-CA-LS-PT EUDAMEDENT Endoscopy Visual System / MGSI-CA-VS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800029902526 EUDAMED18800029902519 EUDAMED
- Basic UDI-DI
- B-18800029902526 EUDAMEDB-18800029902519 EUDAMED88000299GTVS10PP EUDAMED
- Direct Marketing DI
- 18800029902519 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
Light source for endoscope 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-18800029902526 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-18800029902526 | 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 (4)
- EUDAMED b0ea63b8-9381-40b4-a5b0-85b101399049 61 fields · synced Jul 28, 2026
- EUDAMED e00f7e1a-dae5-4afe-8e86-9013b8139f92 61 fields · synced May 19, 2026
- EUDAMED 82b579d8-e003-4dc9-9a5b-f3153827ce2c 61 fields · synced Jul 17, 2026
- EUDAMED 18e28a69-f719-4d2e-a749-d5f278bce983 61 fields · synced Jul 28, 2026