Identity
- Trade Name
- Single-Use Bronchoscope EUDAMED
- Device Name
- Single-Use Bronchoscope EUDAMED
- Model / Reference
- YS-B28 EUDAMEDYS-B5228 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974413710853 EUDAMED
- Basic UDI-DI
- 697441371S001FC EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Single-Use Bronchoscope by Jiangsu Mole Electronic Technology Co., Ltd. — Class IIa — 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 | 697441371S001FC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019981
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 6a015177-0882-4aa8-acc2-7ed531f74fd6 61 fields · synced Jun 19, 2026