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Fluorescence endoscope cold light source
EUDAMEDClass I (EU MDR)
Ref ARGOS LED- 2KNIRModel ARGOS LED- 2KNIR, ARGOS LED -4KNIR
Identity
- Device Name
- Fluorescence endoscope cold light source EUDAMED
- Model / Reference
- ARGOS LED- 2KNIR, ARGOS LED -4KNIR EUDAMEDARGOS LED- 2KNIR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976648890034 EUDAMED
- Basic UDI-DI
- 697664889ARGOLEDEA EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Fluorescence endoscope cold light source by Micro Intelligent Technology (Hunan) Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697664889ARGOLEDEA | Class I | Active |
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Manufacturer
- Manufacturer
- Micro Intelligent Technology (Hunan) Co., LTD
- EUDAMED SRN
- CN-MF-000033494
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED 357a3ded-4459-4f2f-abd3-7546a7313816 61 fields · synced Jun 18, 2026