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Emdyca

Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsVarious instruments for endoscopy and mini-invasive surgery

Gas inflators

EMDN code Z12029008

32 manufacturers, 65 models including 62 on the market, 11 countries

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Manufacturers registered in Europe (EUDAMED) 32
  • 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.
ManufacturerCountryRegistered modelsClassContact
Vimap Spain
3 others
I, IIa 93/42 Website support@vimap.net EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) Japan IIa MDR EUDAMED record Report an error
Novanta FDA Germany IIa, IIb MDR, 93/42 regulatory.affairs@novanta.com EUDAMED record Report an error
Sophway FDA EU representative : Umedwings Netherlands B.V. (Netherlands) China IIa MDR EUDAMED record Report an error
Alan Electronic Systems EU representative : Meddevices Lifesciences B.V. (Netherlands) India IIb 93/42 EUDAMED record Report an error
Gimmi FDA Germany IIa 93/42 Website EUDAMED record Report an error
Karlstorz FDA Germany IIb MDR Website regulatory@karlstorz.com EUDAMED record Report an error
Medexim Slovakia IIa 93/42 Website EUDAMED record Report an error
Richard Wolf FDA Germany IIb MDR, 93/42 info@richard-wolf.com EUDAMED record Report an error
Cardia FDA Sweden IIa 93/42 quality@cardia.se EUDAMED record Report an error
Medivators FDA EU representative : STERIS Ireland Ltd (Ireland) United States IIa 93/42 Website EUDAMED record Report an error
Scivitamedical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR Website info@scivitamedical.com EUDAMED record Report an error
Sonoscape FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR ra@sonoscape.net EUDAMED record Report an error
Wisap Germany IIa MDR, 93/42 EUDAMED record Report an error
Aesculap FDA Germany IIa MDR Website eudamed@bbraun.com EUDAMED record Report an error
BES Italy IIb 93/42 info@besitalia.it EUDAMED record Report an error
Conmed FDA EU representative : MDSS GmbH (Germany) United States IIa 93/42 Website CustomerExperience@conmed.com EUDAMED record Report an error
Endomed Germany IIb MDR Website info@endomed.com EUDAMED record Report an error
Escope Medical (Changzhou) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Hangzhou Xiangrui Medical Equipment EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Healnoc FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China IIb MDR ra-registration@healnoc.com EUDAMED record Report an error
Lexion Medical FDA EU representative : Donawa Lifescience Consulting Srl (Italy) United States IIa 93/42 Website customerservice@lexionmedical.com EUDAMED record Report an error
Meditech Systems FDA EU representative : Clowrey Consultancy Limited (Ireland) United Kingdom (ex Northern Ireland) IIa 93/42 Website admin@meditechsystems.co.uk EUDAMED record Report an error
Micon Germany IIb 93/42 info@micon.info EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Olympus FDA EU representative : Olympus Europa SE & Co. KG (Germany) Japan IIa 93/42 EUDAMED record Report an error
Optomedic FDA China IIb MDR EUDAMED record Report an error
Promepla FDA EU representative : Promepla Group S.à r.l. (Luxembourg) Monaco IIa MDR Website contact@promepla.com EUDAMED record Report an error
RZ-Medizintechnik FDA Germany IIa MDR Website info@rz-medizintechnik.com EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China IIa MDR EUDAMED record Report an error
Surgnova FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR qara@surgnova.com EUDAMED record Report an error
Yearstar Healthcare Technology FDA EU representative : MedPath GmbH (Germany) China I MDR info@yearstarcare.com 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) 73

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.

ManufacturerCountryBrandsFDA clearance
ORANGE SURGICAL INSTRUMENTS, LLC – Lap-port closure device guides 5mm and 10/12 mm ThoraClear Y Connector 3 Ring Suture Passer - Kit Lap Port Closure Device - 15 cm Kit Stainless Steel Cardiac 3 Finger Heart Retractor - Large Joystick for head lamps registered
Northgate Technologies, Inc. United States In-Line Gas Warmer Suction Tubing Set Smith & Nephew Insufflator 500 CO2 Hose and Yoke TAP Tubing Set K120151 (2012)
W.O.M. World of Medicine GmbH United States Insufflator 50L Tube set for insufflation, single-use Heating tube set for insufflation, single use PNEUMOCLEAR Insufflator for Laparoscopy Insufflator K201361 (2020)
Sopro Present in Europe in other categories France COMEG MEDICAL K070783 (2007)
Smith & Nephew, Inc. Present in Europe in other categories United States SMITH & NEPHEW 400 TAP SMITH & NEPHEW 500 registered
ARMM INC. United States Insufflation Tubing Set with Filter Insufflator Filter Assembly Insufflator Tubing Set with Filter Filter Assembly Insufflation Tubing K922245 (1993)
STRYKER CORPORATION Present in Europe in other categories United States Pneumosure K003792 (2001)
DIVERSATEK HEALTHCARE, INC. Present in Europe in other categories United States Diversatek Healthcare registered
TELEFLEX INCORPORATED Present in Europe in other categories United States WECK TAUT registered
Palliare , Ltd. Ireland EVA15 K232902 (2024)
GRI Medical & Electronic Technology Co., Ltd. Present in Europe in other categories China Alleset K172835 (2018)
ADVANCED MEDICAL DESIGN CO., LTD. Taiwan The OR Company-InsufflatOR Needle registered
Accumedx, LLC – AccuMedx registered
Canadian Hospital Specialties Limited Canada STORZ registered
Fisher & Paykel Healthcare, Ltd. Present in Europe in other categories New Zealand Fisher & Paykel Healthcare K162582 (2017)
Freyja Healthcare, LLC United States VereSee K232464 (2024)
Guangzhou T.K Medical Instrument Co.,Ltd. Present in Europe in other categories China GTK K193339 (2020)
Medical Disposables Corp United States MD EndoGuidance Laparoscopic Insufflator registered
Novadaq Technologies, Inc. Canada NOVADAQ®and PINPOINT® registered
TECHMEDICAL SERVICES, INC. – Tech Medical Services Tech Medical Service registered
Unimax Medical Systems, Inc. Present in Europe in other categories Taiwan Veress Needle K111441 (2011)
Core Access Surgical Technologies United States LevaLap 1.0 K212786 (2022)
Ethicon Endo-Surgery, Inc. Present in Europe in other categories United States ENDOPATH K983925 (1999)
Intuitive Surgical, Inc. Present in Europe in other categories United States – registered
LIFE CARE MEDICAL DEVICES LIMITED – Lapcap2 registered
Smartsurgn Inc. United States AirSurgN Insufflator K242772 (2025)
Temed United Kingdom TEMED K173545 (2018)
ARTHREX, INC. Present in Europe in other categories United States – registered
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories United States – registered
ATC Technologiess Inc. United States – registered
Biotec Biotecnologias de Centroamerica S.A. Costa Rica – registered
Buffalo Filter Co., Inc. United States – K171139 (2017)
CBR Enterprise Limited Hong Kong SAR China – registered
Crosmed S.A. Argentina – registered
Demetech AB Sweden – registered
FISHER & PAYKEL HEALTHCARE NZ LTD New Zealand – registered
Farmaco Quimica Nacional, S.A. Dominican Republic – registered
Global Medical Production Ltd China – registered
HARMAC MEDICAL PRODUCTS, INC. United States – registered
HMT Medizintechnik GmbH Present in Europe in other categories Germany – registered
Hangzhou Kangji Medical Instrument Co., Ltd. Present in Europe in other categories China – K232401 (2023)
Hupfer Metallwerke GmbH & Co. KG Germany – registered
I-Medical Asia Company Limited Hong Kong SAR China – registered
Infus Medical (Thailand) Co., Ltd. Thailand – registered
Infus Medical Co., Ltd. Thailand – registered
Jabil Inc. United States – registered
KARL STORZ Endoscopy-America, Inc. United States – K161554 (2017)
Life Science Outsourcing, Inc. United States – registered
MDTGlobal, a.s. Slovakia – registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories United States – K111955 (2011)
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Türkiye – registered
MYRIAD FIBER IMAGING TECHNOLOGIES, INC. United States – registered
Maya Medical Top Trade Ltd. Israel – registered
Medical Wholsale Suplies, Inc, Canada – registered
NBS GROUP SUPPLY- MEDICAL PRODUCTS DIVISION, LLC United States – registered
Norwood Medical United States – registered
Novaprobe Incorporated United States – registered
PHARMCO MEDICAL BV Netherlands – registered
Premium Medical Technology, LLC United States – K231407 (2023)
Purebrand Solutions LTD United Kingdom – registered
Rg Medical USA United States – K072753 (2008)
Sanicure BV Netherlands – registered
Satelec - Acteon Group United States – registered
Sopro - Acteon Group France – K153367 (2016)
SteriPack Asia Sdn Bhd Malaysia – registered
Tautona Group United States – K242536 (2024)
Tautona Group Research & Development, Co., LLC United States – K233020 (2024)
Tianjin Uwell Medical Device Manufacturing Co., Ltd. China – K162648 (2016)
Tribe Medical Group Canada – registered
Unimicro Medical Systems (Shenzhen) Co., Ltd. China – K150068 (2015)
Vietmedical Distribution Joint Stock Company Vietnam – registered
Weyo Surgical Technology , Ltd. Present in Europe in other categories China – K252584 (2026)
Worldwide Supplies Limited Hong Kong SAR China – registered

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