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Single Used Flexible Bronchoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1010110101-BModel BCV1-02
Identity
- Trade Name
- Single-Use flexible Video Bronchoscope FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- Single Used Flexible Bronchoscope EUDAMED
- Model / Reference
- BCV1-02 EUDAMEDFDA UDI1010110101-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972197480016 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972197480016 EUDAMED
- 510(k) Number
- K191828 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- Z12020802 VIDEO 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
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Single Used Flexible Bronchoscope by Hunan Vathin Medical Instrument Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972197480016 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000002593
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f1cd6ecd-c53d-4277-8c6e-2462383177dd 61 fields · synced Jul 23, 2026
- FDA UDI ecaee98d-1073-4753-8554-05c20a6237b7 33 fields · synced May 30, 2026