Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsVarious instruments for general and multidisciplinary surgery
Surgical smoke evacuation systems
EMDN code Z12019004
Manufacturers registered in Europe (EUDAMED) 21
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Conmed FDA EU representative : MDSS GmbH (Germany) | United States |
1 other
|
I MDR | Website CustomerExperience@conmed.com EUDAMED record Report an error |
| Unimax Medical Systems FDA EU representative : mdi Europa GmbH (Germany) | Taiwan | I, IIa 93/42 | Website ra@unimaxmeds.com EUDAMED record Report an error | |
| I.C. Medical FDA EU representative : MDSS GmbH (Germany) | United States | I, IIa MDR | Website inquiry@icmedical.com EUDAMED record Report an error | |
| Karlstorz FDA | Germany | I, IIa MDR | Website regulatory@karlstorz.com EUDAMED record Report an error | |
| Gvs FDA EU representative : GVS S.p.A. (Italy) | United Kingdom (ex Northern Ireland) | I MDR | Website EUDAMED record Report an error | |
| LaproSurge EU representative : Advena Limited (Malta) | United Kingdom (ex Northern Ireland) | I 93/42 | Website info@laprosurge.com EUDAMED record Report an error | |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
I MDR | Website EUDAMED record Report an error |
| Prima Medical EU representative : Obelis s.a. (Belgium) | United Kingdom (ex Northern Ireland) | I MDR | Website EUDAMED record Report an error | |
| Siem Nova | Italy | I MDR | Website info@siemnova.it EUDAMED record Report an error | |
| Stryker FDA EU representative : Stryker European Operations Limited (Ireland) | United States | I MDR | Website EUDAMED record Report an error | |
| Vhmed FDA EU representative : Very Heal Ltd. (Northern Ireland) | China |
|
I 93/42 | Website info@vhmed.com EUDAMED record Report an error |
| Acuderm FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | I MDR | Website EUDAMED record Report an error | |
| Aspensurgical FDA EU representative : Emergo Europe B.V. (Netherlands) | United States |
|
I MDR | Website customerservice@aspensurgical.com EUDAMED record Report an error |
| Cimpax FDA | Denmark | I MDR | Website ra@cimpax.com EUDAMED record Report an error | |
| Covidien FDA EU representative : Medtronic B.V. (Netherlands) | United States | I MDR | EUDAMED record Report an error | |
| Emed | Poland | I MDR | Website EUDAMED record Report an error | |
| Klsmartin FDA | Germany |
|
I MDR | Website vigilance@klsmartin.com EUDAMED record Report an error |
| Limmer Laser | Germany |
|
I MDR | Website eudamed@limmerlaser.de EUDAMED record Report an error |
| Meditech Systems FDA EU representative : Clowrey Consultancy Limited (Ireland) | United Kingdom (ex Northern Ireland) | I 93/42 | Website admin@meditechsystems.co.uk EUDAMED record Report an error | |
| Zhejiang Medstar Technology EU representative : Obelis s.a. (Belgium) | China |
|
I MDR | Website EUDAMED record Report an error |
| O R Pty FDA EU representative : Obelis s.a. (Belgium) No model still on the market | Australia |
|
I MDR | Website EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 170
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH Argyle | registered |
| Microtek Medical LLC | United States | MICROTEK | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES | K213068 (2022) |
| DERMATOLOGIC LAB AND SUPPLY, INC. | United States | Geiger Smoke Evacuator Filter Delasco SaftEvac Filter Geiger Viral Filter Delasco SaftEvac Geiger Odor Filter Geiger Smoke Evacuator | registered |
| COASTAL LIFE TECHNOLOGIES, INC. | – | Surgimedics® | registered |
| Cardinal Health, Inc. Present in Europe in other categories | United States | Argyle | registered |
| Dynarex Corporation | United States | Suction Tubing w/Straw Connector Resp-O2 Suction Connecting Tubing, Non-Conductive Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented Resp-O2 Yankauer Suction Handles, Bulb Tip, Non-Vented Suction Tubing Combo Pack w/Straw Connector Resp-O2 Suction Tubing Combo Pack | registered |
| CUSTOM ASSEMBLIES, INC. | United States | Custom Medical Specialties, Inc. Custom Medical Specialties | registered |
| GRI Medical & Electronic Technology Co., Ltd. Present in Europe in other categories | China | Alleset | registered |
| INVOTEC INTERNATIONAL, INC. | United States | Silicone Tubing | registered |
| WELMED INC. | United States | Welmed | registered |
| AXIOM MEDICAL, INCORPORATED | United States | Axiom® | registered |
| Bio Protech, Inc. Present in Europe in other categories | United States | EvaQMax Laparo | K192035 (2019) |
| BEMIS MANUFACTURING COMPANY | United States | Bemis | registered |
| BIOSEAL | United States | Bioseal Bioseal Inc. | registered |
| Drive Devilbiss Healthcare | United States | Roscoe Medical Drive DRIVEMEDICAL | registered |
| MEDIMAX TECH INC. | – | MediMax Tech MediMaxTech Inc. | registered |
| CUTTING EDGE HC BRANDS LLC | – | O2-Life™ | registered |
| Megadyne Medical Products, Inc. Present in Europe in other categories | United States | MEGADYNE E-Z LINK ZIP Pen FLUID TRAP | K200250 (2020) |
| Twin Med, LLC | – | ProCure | registered |
| BLACK & BLACK SURGICAL, INC. Present in Europe in other categories | United States | INFILTRATION TUBING Aspiration Tubing | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| Drägerwerk AG & Co. KGaA Present in Europe in other categories | Germany | Vacusmart Tube (2m) Silicone hose 6x2,5 2m TN500 Suction accessories Hose 5X2SI 60SHA NF M25779 Secretion control glass Suction hose | registered |
| Medco Manufacturing LLC | – | Medco Manufacturing Inc | registered |
| SKYTRON LLC | United States | Skytron SkyVac Skytron Smoke Evacuation | registered |
| Zinnanti Surgical Design Group Inc | United States | Zinnanti Surgical | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | – | registered |
| DIVERSATEK HEALTHCARE, INC. Present in Europe in other categories | United States | Diversatek Healthcare | registered |
| MICROSPECIALITIES, INC. | – | – | registered |
| Medisourcenet, Inc | – | MediSourceNet, Inc | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | PLEUR-EVAC | registered |
| Wells Johnson Co. | United States | "Y" Small Bore Infiltration Tubing Standard Ultra-Limp Tubing CB Infiltration Tubing Large Bore Infiltration Tubing HVP Tubing MB ULTRA-LIMP TUBING | K832519 (1983) |
| Allied Medical, LLC Present in Europe in other categories | United States | BF PC | registered |
| Biomet Orthopedics, LLC Present in Europe in other categories | United States | REDI-FLOW FILTER® SYSTEM REDI-FLOW FILTER(R) SYSTEM | registered |
| Pacific Hospital Supply Company Limited Present in Europe in other categories | Taiwan | SSCOR, INC. GBUK GROUP LIMITED PAHSCO | registered |
| SUNSET HEALTHCARE SOLUTIONS, INC. | United States | CPAP Tube 6 ft Sunset Healthcare Solutions Silicone Suction Tubing Connector - 6in Sunset Healthcare Solutions Silicone Suction Tubing Connector - 3.5in Silicone Suction Tubing Connector Sunset Healthcare Solutions Silicone Suction Tubing Connector - 16in | registered |
| KITAZATO CORPORATION | Japan | KITAZATO VACUUM LINE | registered |
| Prabadin Corp | – | Prabadin | registered |
| RUMEX INTERNATIONAL CORP. | United States | Rumex | registered |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| Cynosure, Inc. Present in Europe in other categories | United States | SURG-E-VAC SMOKE EVACUATION SYSTEM | registered |
| NASCENT SURGICAL, LLC | United States | Flamingo Funnel (microSQUAIR) - Medium Flamingo Funnel (nanoSQUAIR) - Small Flamingo Funnel (miniSQUAIR) - Large | registered |
| Northgate Technologies, Inc. | United States | NEBULAE SRS Laparoscopic Surgical Pump NEBULAE SRS Tubing Set Nebulae Smoke Evacuation Tubing Set | K202944 (2021) |
| Sun Medical, Inc. | United States | Sun Medical Inc | K911154 (1991) |
| Vitrolife Sweden AB Present in Europe in other categories | Sweden | Vacuum Pump Tubing | registered |
| ARTHREX, INC. Present in Europe in other categories | United States | Arthrex® | registered |
| AVID MEDICAL, INC. | – | Halyard AVID TruCustom | registered |
| HK SURGICAL INC. | United States | Heavy Aspiraton Tubing Aspiration Tubing | registered |
| Hartman Medical Group LLC | United States | HMG | registered |
| Hayden Medical, Inc. | – | Hayden Medical | registered |
| Pall International Sàrl Present in Europe in other categories | United States | Pall LaparoShield® Plus Laparoscopic Smoke Filtration System Pall LaparoShield® Plus Laparoscopic Smoke Filter | registered |
| STERIS Corporation Present in Europe in other categories | United States | HarmonyAIR | K991167 (1999) |
| Utah Medical Products, Inc. Present in Europe in other categories | United States | FILTRESSE | K952981 (1995) |
| A1 SURGICAL SUPPLIES, LLC | – | G.E.B. tubing | registered |
| ADDITION TECHNOLOGY, INC. | United States | Intacs Sterile Vacuum Tubing | registered |
| ARMM INC. | United States | Smoke Filter with Tube | registered |
| Avalign Technologies, Inc. | United States | Millennium | registered |
| CENTURION MEDICAL PRODUCTS CORPORATION | United States | Centurion | registered |
| Ethicon Endo-Surgery, Inc. Present in Europe in other categories | United States | Megadyne | registered |
| FLEXICARE MEDICAL LIMITED Present in Europe in other categories | United Kingdom | Suction Tubing 0.5m (18") | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | Gyrus ACMI | registered |
| Hydrafacial LLC Present in Europe in other categories | United States | SAFE® System Surgical Smoke Evacuator | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| MENTOR TEXAS L.P. | United States | Aseptic Fluid Transfer Set | registered |
| Medela AG Present in Europe in other categories | Switzerland | Freestyle Flex Tubing | registered |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Premier | registered |
| PURPLE SURGICAL INTERNATIONAL LIMITED Present in Europe in other categories | United Kingdom | Collection set | registered |
| STRADIS MEDICAL, LLC | – | STRADIS HEALTHCARE | registered |
| 15445361 Canada Inc. | Canada | – | registered |
| AG Industries | United States | – | registered |
| ASANUS MEDIZINTECHNIK GMBH | Germany | – | registered |
| ATLANTA HEALTHCARE SERVICES | United States | – | registered |
| Aesculap, Inc. Present in Europe in other categories | United States | – | registered |
| Alleset, Inc. | United States | – | registered |
| Anhui Careplus Medical Technology Co., Ltd. | China | – | registered |
| Arrow Medsource Group Limited | China | – | registered |
| B.Braun Medical, Inc. Present in Europe in other categories | United States | – | registered |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | – | registered |
| Biotec Biotecnologias de Centroamerica S.A. | Costa Rica | – | registered |
| Boyd Weiler GmbH & Co. KG | Germany | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COMMAND MEDICAL PRODUCTS, LLC | United States | – | registered |
| Changzhou Rongxin Medicine Minimal Invasion Tech. Co., Ltd. | China | – | registered |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., L | China | – | registered |
| Clunas AG | Poland | – | registered |
| Compass Health Brands (Corporate Office) | United States | – | registered |
| Cook, Inc. | United States | – | registered |
| DRW MEDICAL LLC | United States | – | registered |
| Dong Guan Queenmed Equipment Mfg Co Ltd | China | – | registered |
| Draegerwerk AG & CO Kgaa | Germany | – | registered |
| EXACT MEDICAL MANUFACTURING, INC. | China | – | registered |
| Excellent Medical Technology (Thailand) Co., Ltd. | Thailand | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| Fresenius Kabi AG Present in Europe in other categories | Germany | – | registered |
| GBUK GROUP LIMITED Present in Europe in other categories | United Kingdom | – | registered |
| GCMEDICA ENTERPRISE LTD.(WUXI) | China | – | registered |
| GPE MedTech Systeme GmbH | Germany | – | registered |
| GST CORPORATION LIMITED Present in Europe in other categories | India | – | registered |
| Gebruder Renggli AG | Switzerland | – | registered |
| Global Life Sciences Solutions USA LLC | United States | – | registered |
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