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Single use flexible bronchoscope
EUDAMEDClass IIa (EU MDR)
Ref BR-F2Model BR-D1,BR-D2,BR-D3,BR-D4,BR-F1,BR-F2,BR-F3,BR-F4Ref BR-D1Ref BR-F1Ref BR-D2Ref BR-F3
Identity
- Trade Name
- Single use flexible bronchoscope EUDAMED
- Device Name
- Single use flexible bronchoscope EUDAMED
- Model / Reference
- BR-D1,BR-D2,BR-D3,BR-D4,BR-F1,BR-F2,BR-F3,BR-F4 EUDAMEDBR-F2 EUDAMEDBR-D1 EUDAMEDBR-F1 EUDAMEDBR-D2 EUDAMEDBR-F3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355350765 EUDAMED06971355350710 EUDAMED06971355350758 EUDAMED06971355350727 EUDAMED06971355350772 EUDAMED
- Basic UDI-DI
- 69713553501928Q EUDAMED
- EMDN Code
- Z12020801 BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 Shenzhen Besdata 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 | 69713553501928Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Besdata Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018921
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 43025e2d-43c8-4a82-b374-c158df5f92e7 61 fields · synced Jul 28, 2026
- EUDAMED 60cdbfb0-ee95-4626-acf1-465708a588b7 61 fields · synced May 16, 2026
- EUDAMED e3ba25b6-a15f-4e2b-82ea-565a6b02a4ec 61 fields · synced May 17, 2026
- EUDAMED cdc402e1-efcd-4a13-bb96-2ee97248c4b3 61 fields · synced May 18, 2026
- EUDAMED 4a46e447-dce4-492c-8a1f-f7dd8ec84693 61 fields · synced May 18, 2026