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Smoke Set

FDA UDIEUDAMED
Ref 2200/47BBKBTUA001/0001Ref 2200/47BAUA092/0001Ref 2200/47BBKBARA001/0001Ref 2200/47BBKZTUA001/0001Ref 2200/47BBKBTRA001/0001

by Gvs Filter Technology Uk Ltd

Identity

Trade Name
Smoke Set EUDAMEDFDA UDI
Generic Name
Suction system filter, plume particulate FDA UDI
Device Name
Gas Filters EUDAMED
Gas and Suction Filters EUDAMED
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
Model / Reference
2200/47BBKBTUA001/0001 EUDAMED
2200/47BAUA092/0001 EUDAMED
2200/47BBKBARA001/0001 EUDAMED
2200/47BBKZTUA001/0001 EUDAMED
2200/47BBKBTRA001/0001 EUDAMED
2200/47BDKBTUA123/0001 FDA 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
2200/47BDK FDA UDI
Primary DI / UDI-DI
05060120955999 EUDAMED
05060120955975 EUDAMED
05056845200193 EUDAMED
05060120956002 EUDAMED
05056845200063 EUDAMED
15060120959710 FDA UDI
Basic UDI-DI
506012095Cat379 EUDAMED
506012095Class1L9 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 UDIEUDAMED

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 Set by Gvs Filter Technology Uk Ltd — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Suction system filter, plume particulate.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gvs Filter Technology Uk Ltd

Sources (6)

  • FDA UDI 826ca8a0-a750-4696-8c87-87e6e31a733e 34 fields · synced Jul 18, 2026
  • EUDAMED a4d2434c-4daa-4c61-8e3f-7db68190b05f 61 fields · synced Jul 9, 2026
  • EUDAMED d126ceb0-e9b2-43fa-8939-889e677e4af7 61 fields · synced Jul 10, 2026
  • EUDAMED 70009020-f3c1-4a32-9a1d-7c3e210ff630 61 fields · synced Jul 13, 2026
  • EUDAMED c56b0a42-8ff4-42a2-8033-cf61f5ec39e5 61 fields · synced Jul 14, 2026
  • EUDAMED 3b2a02e6-0ec6-47fa-aaab-19a7e551171b 61 fields · synced Jul 18, 2026