← Back to catalogue
Endoscopic Led Cold Light Source
EUDAMEDClass I (EU MDR)
Ref CN-MF-000032512Model ELL-080A; ELL-080B; ELL-080C
Identity
- Trade Name
- Endoscopic Led Cold Light Source EUDAMED
- Device Name
- Endoscopic LED Cold Light Source EUDAMED
- Model / Reference
- ELL-080A; ELL-080B; ELL-080C EUDAMEDCN-MF-000032512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975043220576 EUDAMED06975043220583 EUDAMED
- Basic UDI-DI
- 697504322ELL00CQ EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Category: Endoscopic light source unit, line-powered
Endoscopic Led Cold Light Source by Zhejiang Healnoc Technology CO., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic light source unit, line-powered.
- Light Sources, Fiberoptic — STEMA Medizintechnik GmbH · Class I
- SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- 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 (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 | 697504322ELL00CQ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Healnoc Technology CO., LTD
- EUDAMED SRN
- CN-MF-000032512
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 5b216e79-253a-4cf5-a086-6f72e54972b6 61 fields · synced Jul 12, 2026
- EUDAMED ed4b5c8f-8077-44af-89ce-4fab247435f1 61 fields · synced May 17, 2026