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Single-use Flexible Bronchoscope
EUDAMEDClass IIa (EU MDR)
Ref SBF22Model SBF22、SBF28、SBF49、SBF52、SBF58、SBF62
Identity
- Device Name
- Single-use Flexible Bronchoscope EUDAMED
- Model / Reference
- SBF22、SBF28、SBF49、SBF52、SBF58、SBF62 EUDAMEDSBF22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971558931075 EUDAMED
- Basic UDI-DI
- 697155893SBFVW EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Flexible Bronchoscope by Zhuhai Vision Medical 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 | 697155893SBFVW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Vision Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000016785
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED faee475a-abbf-482b-bfb2-8c779d1b6c29 61 fields · synced Jun 19, 2026