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4K 3D Endoscopic Fluorescence Camera System
EUDAMEDClass I (EU MDR)
Ref HORUS CAM-4030N
Identity
- Trade Name
- 4K 3D Endoscopic Fluorescence Camera System EUDAMED
- Device Name
- 4K 3D Endoscopic Fluorescence Camera System EUDAMED
- Model / Reference
- HORUS CAM-4030N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976982090920 EUDAMED
- Basic UDI-DI
- 6976982093DEFCSN3 EUDAMED
- Direct Marketing DI
- 16976982090920 EUDAMED
- EMDN Code
- Z11069080 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 3D Endoscopic Fluorescence Camera System by Shinevia (Shandong) Technology 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 | 6976982093DEFCSN3 | Class I | Active |
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Manufacturer
- Manufacturer
- Shinevia (Shandong) Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000049465
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED ffe55d79-1bfd-4b92-aee0-8495e5f3588c 61 fields · synced Jun 19, 2026