LED Light Source
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- LED Light Source EUDAMEDFDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- LED Light Source EUDAMEDThe product is composed of a main equipment, a light guide cable and a power cable.The purpose of this product is to provide illumination for optical observation or electronic endoscope rear camera system, not for human eye observation optical endoscope lighting. FDA UDI
- Model / Reference
- ES-LS100D,ES-LS110D EUDAMEDES-LS110D EUDAMEDFDA UDI
- Description
- The product is composed of a main equipment, a light guide cable and a power cable.The purpose of this product is to provide illumination for optical observation or electronic endoscope rear camera system, not for human eye observation optical endoscope lighting. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381250114 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125003A85 EUDAMED
- Direct Marketing DI
- 06971381250114 EUDAMED
- FDA Product Code
- NTN FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic light source unit, line-powered
LED Light Source by Scivita Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic light source unit, line-powered.
- Light Sources, Fiberoptic — STEMA Medizintechnik GmbH · Class I
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- Endoscope Light Source — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class I
- SL-EL200 — SONOSCAPE MEDICAL CORP. · Class IIa
- LED 610 Light source — Erbe Vision GmbH · Class I
- SPOTLIGHT — Depuy Spine, Inc. · Class II
- SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
- FUJIFILM — FUJIFILM Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697138125003A85 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 6a1a4300-6cc0-40c4-a500-7e8b12254d7e 61 fields · synced Jun 20, 2026
- FDA UDI 28f7235d-50da-4901-8fa0-9e52cb87312c 34 fields · synced May 30, 2026