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Integrated Dual-screen Display
EUDAMEDFDA 510(k)Class A (EU MDR)
Ref C82W+ Model C82W+, C811W, C811WT, C821W, C821WT, C822W, P2420, P2740, P2780
Identity
- Device Name
- Integrated Dual-screen Display EUDAMED
- Model / Reference
- C82W+, C811W, C811WT, C821W, C821WT, C822W, P2420, P2740, P2780 EUDAMEDC82W+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970027827000 EUDAMED
- Basic UDI-DI
- 697002782IDSD001HM EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Integrated Dual-screen Display by Shenzhen Beacon Display Technology Co., Ltd. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K853130 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 697002782IDSD001HM | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Beacon Display Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008774
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ea78b3bf-df57-403a-9102-469929c9962c 61 fields · synced Jul 15, 2026
- FDA 510(k) K853130 1 fields · synced May 18, 2026