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Single Use Flexible Video Bronchoscope
EUDAMEDClass IIa (EU MDR)
Ref PB4122A (Standard Deflection)Model BF220-312R, BF220-312S, BF220-528R, BF220-528S, PB2512A, PB4122A, PB4828A, PB5232A
Identity
- Device Name
- Single Use Flexible Video Bronchoscope EUDAMED
- Model / Reference
- BF220-312R, BF220-312S, BF220-528R, BF220-528S, PB2512A, PB4122A, PB4828A, PB5232A EUDAMEDPB4122A (Standard Deflection) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971176280807 EUDAMED
- Basic UDI-DI
- 697117628CDJ 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 Flexible Video Bronchoscope by Zhuhai Pusen 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 | 697117628CDJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Pusen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009220
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3b0f2177-4037-46c0-8b83-bc8989581ab5 61 fields · synced May 29, 2026