Identity
- Trade Name
- LungVision EUDAMEDLungVision Tool FDA UDI
- Generic Name
- Bronchoscopic catheter FDA UDI
- Device Name
- LungVision Tool EUDAMEDThe LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system. LungVision Tool, LV2055021 is compatible with Olympus Bronchoscope BF-1TH190 LungVision Tool composed from: LungVision Handle, LungVision Adaptor with seal for Olympus Bronchoscope BF-1TH190, LungVision 210 Curved Sheath and LungVision Stylet FDA UDI
- Model / Reference
- Bridge EUDAMEDFDA UDILV2055021 EUDAMED
- Description
- The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system. LungVision Tool, LV2055021 is compatible with Olympus Bronchoscope BF-1TH190 LungVision Tool composed from: LungVision Handle, LungVision Adaptor with seal for Olympus Bronchoscope BF-1TH190, LungVision 210 Curved Sheath and LungVision Stylet FDA UDI
Identifiers
- Catalog Number
- LV2055021 FDA UDI
- Primary DI / UDI-DI
- 07290017652122 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290017652BVMTOOLPN EUDAMED
- Direct Marketing DI
- 07290017652122 EUDAMED
- 510(k) Number
- K172955 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- R070199 BRONCHOPULMONARY ENDOSCOPY PROBES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Bronchoscopic catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- Italy 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
Yes
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
LungVision by Body Vision Medical — Class I — 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 | 7290017652BVMTOOLPN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Body Vision Medical
- EUDAMED SRN
- IL-MF-000021610
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED a3327936-2f96-488c-a0b4-b87c11653bb9 61 fields · synced Jul 31, 2026
- FDA UDI f01fa660-857e-4165-83e8-62f35e3be8f7 35 fields · synced May 30, 2026