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Bonss
EUDAMEDClass I (EU MDR)
Ref N/AModel ES-HD1、ES-HD2、ES-4K1、ES-4K2、TS-HD1、TS-HD2、LS-HD1、LS-HD2、ETS-HD1、ETS-HD2
Identity
- Trade Name
- BONSS EUDAMED
- Device Name
- Endoscopic Camera System EUDAMED
- Model / Reference
- ES-HD1、ES-HD2、ES-4K1、ES-4K2、TS-HD1、TS-HD2、LS-HD1、LS-HD2、ETS-HD1、ETS-HD2 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927155330018 EUDAMED
- Basic UDI-DI
- 69271553BONSS0406D EUDAMED
- Direct Marketing DI
- 06927155330018 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY 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
Category: Endoscopic light source unit, line-powered
Bonss by Jiangsu Bonss Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69271553BONSS0406D | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bonss Medical Technology Co Ltd
- EUDAMED SRN
- CN-MF-000023743
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 1be45cb8-1e9d-4b47-884d-77f03f94dcdb 61 fields · synced May 29, 2026