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UE BRONCHO Single-Use Bronchoscopes
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 104000017200Model EBS-380C, EBS-500C, EBS-600C, EBS-380K, EBS-500K, EBS-600KRef 102000039900Ref 104000017100Ref 104000102300
Identity
- Device Name
- UE BRONCHO Single-Use Bronchoscopes EUDAMED
- Model / Reference
- EBS-380C, EBS-500C, EBS-600C, EBS-380K, EBS-500K, EBS-600K EUDAMED104000017200 EUDAMED102000039900 EUDAMED104000017100 EUDAMED104000102300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970283489141 EUDAMED06937048206535 EUDAMED06970283489134 EUDAMED06937048206559 EUDAMED
- Basic UDI-DI
- 697028348UE000001HX EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
UE BRONCHO Single-Use Bronchoscopes by Zhejiang UE Medical Corp. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251823 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697028348UE000001HX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang UE Medical Corp.
- EUDAMED SRN
- CN-MF-000003020
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED cfe2efc1-f3b4-4691-a3ac-b52a716153f7 61 fields · synced Sep 18, 2026
- EUDAMED 7cf95b41-7c0f-4fa1-96f8-4a56f93dd9b8 61 fields · synced May 17, 2026
- EUDAMED cd05e832-0aed-414a-a805-7c81ba71be0e 61 fields · synced May 17, 2026
- EUDAMED df344009-25c3-486e-945b-fb554f62c6f5 61 fields · synced May 19, 2026
- FDA 510(k) K251823 1 fields · synced May 18, 2026