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Single-Use Bronchoscope
EUDAMEDClass IIa (EU MDR)
Ref YS-B6032Model YS-B28Ref YS-B4822Ref YS-B38Ref YS-B5226Ref YS-B3112Ref YS-B4926
Identity
- Trade Name
- Single-Use Bronchoscope EUDAMED
- Device Name
- Single-Use Bronchoscope EUDAMED
- Model / Reference
- YS-B28 EUDAMEDYS-B6032 EUDAMEDYS-B4822 EUDAMEDYS-B38 EUDAMEDYS-B5226 EUDAMEDYS-B3112 EUDAMEDYS-B4926 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974413710877 EUDAMED06974413710822 EUDAMED06974413710792 EUDAMED06974413710846 EUDAMED06974413710808 EUDAMED06974413710839 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 (6)
- EUDAMED c4525c0d-cc2a-45c8-8d09-3617941076ed 61 fields · synced Jul 27, 2026
- EUDAMED fdbab9b4-d6e2-4ea2-b4dd-20877a62d5e7 61 fields · synced May 16, 2026
- EUDAMED 73d2f797-aef7-4e2a-bcf1-60e476727bb6 61 fields · synced May 17, 2026
- EUDAMED 1a356025-fbb2-430a-9cb7-625debd7b681 61 fields · synced May 17, 2026
- EUDAMED 3b0fa843-15af-45ea-8e15-ca7439f8158e 61 fields · synced May 17, 2026
- EUDAMED 06f6eb21-49ac-4009-9563-f87816816de2 61 fields · synced May 18, 2026