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Single-use flexible Video Bronchoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1010110170Model BCV1- U2
Identity
- Trade Name
- Single-Use flexible Video Bronchoscope FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- Single-use flexible Video Bronchoscope EUDAMED
- Model / Reference
- BCV1- U2 EUDAMED1010110170 EUDAMEDBCV1-U2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972197480191 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972197480191 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-use flexible Video 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-06972197480191 | 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 4af4527b-a176-4c14-bd1a-ab3cdf976cd7 61 fields · synced Jul 11, 2026
- FDA UDI acacab3f-a9a3-4f23-a1e0-8cac91637aa7 33 fields · synced May 30, 2026