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Single-Use Bronchoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BC28-3Model BC12-1、BC12-2、BC20-1、BC20-2、BC22-1、BC22-2、BC22-3、BC28-1、BC28-2、BC28-3
Identity
- Trade Name
- Endoso FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- Single-Use Bronchoscope EUDAMED
- Model / Reference
- BC12-1、BC12-2、BC20-1、BC20-2、BC22-1、BC22-2、BC22-3、BC28-1、BC28-2、BC28-3 EUDAMEDBC28-3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975202770195 EUDAMEDFDA UDI
- Basic UDI-DI
- 697520277YS004L7 EUDAMED
- Direct Marketing DI
- 06975202770195 EUDAMED
- 510(k) Number
- K231107 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- Z12020801 BRONCHOSCOPES EUDAMED
- GMDN Term
- Flexible video bronchoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Single-Use Bronchoscope by Hunan Endoso Life Technology Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697520277YS004L7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 7b348230-ec04-4f59-bd8a-32ebc232577b 61 fields · synced Jun 18, 2026
- FDA UDI af07dd59-5797-469e-8d3c-e97c86840e79 33 fields · synced May 30, 2026