Identity
- Trade Name
- Fluorescence Camera System EUDAMED
- Device Name
- Fluorescence Camera System EUDAMED
- Model / Reference
- ARGOS NIR-320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976982090852 EUDAMED
- Basic UDI-DI
- 697698209FCSY5 EUDAMED
- Direct Marketing DI
- 16976982090852 EUDAMED
- EMDN Code
- Z11069080 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
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 | 697698209FCSY5 | 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 88b28268-e0b1-453f-941b-356274505bcc 61 fields · synced Jun 19, 2026