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Single-use Broncho Videoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SBV-1C-BModel SBV-1A-B, SBV-1A-P,SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P
Identity
- Trade Name
- Single-use Broncho Videoscope EUDAMEDFDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- Single-use Broncho Videoscope EUDAMEDThe product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs. FDA UDI
- Model / Reference
- SBV-1A-B, SBV-1A-P,SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P EUDAMEDSBV-1C-B EUDAMEDFDA UDI
- Description
- The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381254716 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125010A7Z EUDAMED
- Direct Marketing DI
- 06971381254716 EUDAMED
- 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
- Belgium 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
Yes
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
Yes
FDA UDI
Single-use Broncho Videoscope by Scivita Medical 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 | 697138125010A7Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 6d0060fd-98a5-4f97-a2ca-5994a4cc22e9 61 fields · synced May 30, 2026
- FDA UDI 8c34dd85-2d09-4eba-b933-eed20213282c 34 fields · synced May 30, 2026