4K 3D Endoscopic Fluorescence Camera System
by Shinevia (Shandong) Technology Co., Ltd. 7 variants
Ref PRO CAM-5134K
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6976982093DEFCSN3 16976982090951 | Date12 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- PRO CAM-5134K
- Primary DI / UDI-DI
- 16976982090951
- Basic UDI-DI
- 6976982093DEFCSN3
- Direct Marketing DI
- 16976982090951
- EMDN Code
- Z11069080 Various digital bioimaging management instruments - hardware accessories
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000049465
- Authorised representative
- Everbiz GmbH DE-AR-000008964
Other devices from Shinevia (Shandong) Technology Co., Ltd.
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Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No