Identity
- Device Name
- Medical Grade Monitor EUDAMED
- Model / Reference
- S3281P EUDAMEDE3280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970027821527 EUDAMED
- Basic UDI-DI
- 697002782001FH EUDAMED
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Medical Grade Monitor by Shenzhen Beacon Display 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 | 697002782001FH | Class I | 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 (1)
- EUDAMED 4d175216-8587-42c5-8616-2e0ecd334d4d 61 fields · synced Jun 18, 2026