Identity
- Trade Name
- Smoke Gas Evacuation Tube Set EUDAMEDFDA UDI
- Generic Name
- Suction system filter, plume particulate FDA UDI
- Device Name
- Gas Filters EUDAMEDThe combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing noxious chemicals from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision. It is indicated for use during any minimally invasive surgery involving insufflation, laser, or ultrasonic scalpel use. It is recommended that the surgeon and their team wear N95/FFP3 face mask during surgery. FDA UDI
- Model / Reference
- 2200/72BTUA123/0001 EUDAMEDFDA UDI
- Description
- The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing noxious chemicals from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision. It is indicated for use during any minimally invasive surgery involving insufflation, laser, or ultrasonic scalpel use. It is recommended that the surgeon and their team wear N95/FFP3 face mask during surgery. FDA UDI
Identifiers
- Catalog Number
- 2200/72 FDA UDI
- Primary DI / UDI-DI
- 05060120959775 EUDAMED15060120959772 FDA UDI
- Basic UDI-DI
- 506012095Cat379 EUDAMED
- EMDN Code
- Z12019004 SURGICAL SMOKE EVACUATION SYSTEMS EUDAMED
- GMDN Term
- Suction system filter, plume particulate FDA UDI
Classification
- Device Class
- Class I EUDAMED
- 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
Category: Suction system filter, plume particulate
Smoke Gas Evacuation Tube Set by Gvs Filter Technology Uk Ltd — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Gvs Filter Technology Uk Ltd
Sources (2)
- FDA UDI 50e0c597-a686-4955-9ca6-8f9cca76560c 34 fields · synced Oct 6, 2026
- EUDAMED 6b2ee566-baba-4f65-88fb-526cc0aaacce 61 fields · synced Jul 28, 2026