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4K endoscopic fluorescence camera system
EUDAMEDClass I (EU MDR)
Ref ARGOS CAM-4KBModel ARGOS CAM-4KB, ARGOS CAM-4KC， ARGOS CAM-4KD, ARGOS CAM-4KE
Identity
- Device Name
- 4K endoscopic fluorescence camera system EUDAMED
- Model / Reference
- ARGOS CAM-4KB, ARGOS CAM-4KC， ARGOS CAM-4KD, ARGOS CAM-4KE EUDAMEDARGOS CAM-4KB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976648890010 EUDAMED
- Basic UDI-DI
- 697664889ARGOSFLUOCAMKM EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES 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
4K endoscopic fluorescence camera system by Micro Intelligent Technology (Hunan) Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697664889ARGOSFLUOCAMKM | 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 b193fd80-0d7d-4819-a5fc-61bf83a7bde8 61 fields · synced Jun 19, 2026