Identity
- Trade Name
- Monitor S320P3D EUDAMED
- Device Name
- Monitor EUDAMED
- Model / Reference
- S320P3D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973519703943 EUDAMED
- Basic UDI-DI
- 697351970MDC0001JN EUDAMED
- Direct Marketing DI
- 06973519703943 EUDAMED
- EMDN Code
- Z12020499 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Monitor S320P3D by Shanghai Aohua Photoelectricity Endoscope 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 | 697351970MDC0001JN | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Aohua Photoelectricity Endoscope Co., Ltd.
- EUDAMED SRN
- CN-MF-000030035
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ef13f789-e42e-4fb4-968b-55e3b6ea62f1 61 fields · synced Jul 23, 2026