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4K endoscopic fluorescence camera system
EUDAMEDClass I (EU MDR)
Ref HORUS CAM-4100B
Identity
- Trade Name
- 4K endoscopic fluorescence camera system EUDAMED
- Device Name
- 4K endoscopic fluorescence camera system EUDAMED
- Model / Reference
- HORUS CAM-4100B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976982090883 EUDAMED
- Basic UDI-DI
- 697698209EFCSU9 EUDAMED
- Direct Marketing DI
- 16976982090883 EUDAMED
- EMDN Code
- Z11069080 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 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 | 697698209EFCSU9 | 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 11c170a2-01fc-455e-b904-5442c8b01c6e 61 fields · synced Jul 10, 2026