Instruments for functional explorations and therapeutic interventionsPneumonology and respiratory physiopathology instrumentsVarious pneumology and respiratory physiopathology instruments

Equipment for removal of secretions

EMDN code Z12159009

16 manufacturers, 32 models including 31 on the market, 11 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 16

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
Medical Products Research	Italy	ATENA70 COM+ MPR10-00KIT-01 LIBERA + MPR10-00KIT-013 refs ATENA70 LIBERA3 refs Free Aspire Hybrid IE PLUS93/42 KALOS93/42 1 other KINEX93/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Asskea FDA	Germany	ASSKEA M20 avec système de récipient réutilisable3 refs ASSKEA M20 Secretion Aspirators3 refs ASSKEA ped M93/42 ASSKEA procuff M Cuff Aspirators3 refs	IIa MDR, 93/42	Website EUDAMED record Report an error
Dima Italia FDA	Italy	PEGASO E7A93/42 PEGASO E7B93/42 PEGASO E7C93/42 PP00000882 PE00000882	I, IIb MDR, 93/42	EUDAMED record Report an error
Hill-Rom Services Pte FDA EU representative : Welch Allyn Limited (Ireland)	Singapore	Optimus Handset Module93/42 Single Patient Use Circuit for Volara™ therapy2 refs93/42 Single Patient Use Circuit for Volara™ therapy (5 Pack Module)93/42 Volara System4 refs93/42	IIa 93/42	Website EUDAMED record Report an error
EOVE	France	AC-70 Secretion Management Device EO-70 Secretion Management Device2 refs EO-300 IPPB Device	IIb MDR	contact@eove.fr EUDAMED record Report an error
Breas FDA EU representative : Breas Medical AB (Sweden)	Sweden, United Kingdom (ex Northern Ireland)	Clearo Clearway 293/42 (no longer marketed)	IIb MDR, 93/42	Website orders@nippyventilator.com EUDAMED record Report an error
Dalian Labtek Science & Development FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	VIB Cough-vest LBTK-K-I 2000	IIa MDR	EUDAMED record Report an error
Flexicare FDA EU representative : Flexicare EU Ops Ltd (Northern Ireland)	United Kingdom (ex Northern Ireland)	Flutter	I MDR	regulatory@flexicare.com EUDAMED record Report an error
Intersurgical FDA EU representative : UAB Intersurgical (Lithuania)	United Kingdom (ex Northern Ireland)	Positive Expiratory Pressure (PEP) Therapy device3 refs	I MDR	Website EUDAMED record Report an error
Karlstorz FDA	Germany	Aspirators 10432N	I MDR	Website regulatory@karlstorz.com EUDAMED record Report an error
Maisindia EU representative : Obelis s.a. (Belgium)	India	Mais Suction Set™ Yankauer Handle with/without Connecting Tube, Yankauer Tube with Connector & Handle/without Connector & Handle - Standard Tip/Crown Tip (DEHP & DEHP Free)	IIa MDR	Website qa@maisindia.in EUDAMED record Report an error
Promeba	Spain	ASPIRADOR DE SECRECIONES MANUAL	I MDR	Website EUDAMED record Report an error
Rokána Kft	Hungary	BIOSYNEX3 refs	I MDR	EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands)	China	High Frequency Chest Wall Oscillator PQ63 refs	IIa MDR	EUDAMED record Report an error
Solutions	Netherlands	Solutions Company FLT	I MDR	Website EUDAMED record Report an error
T-Tex	Italy	2EASY IRRIGATORE NASALE PER ADULTI E BAMBINI 300ML	I MDR	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) 18

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
Ventec Life Systems, Inc.	United States	VOCSN Patient Breathing Package VOCSN VOCSN High Flow Kit VOCSN Patient Air Intake Filters VOCSN Power Supply VOCSN Fan Filters	registered
Respironics, Inc. Present in Europe in other categories	United States	CoughAssist DirectView ATOS	K121955 (2012)
Percussionaire Corp.	United States	Percussionaire	K905236 (1991)
Abmrc, LLC	United States	BiWaze Clear Dual Lumen Circuit - Acute BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium BiWaze Clear Dual Lumen Circuit With Mouthpiece BiWaze Cough BiWaze Clear Dual Lumen Circuit With Face Mask - Child BiWaze Clear Dual Lumen Circuit With Trach Adapter	K260604 (2026)
Vortran Medical Technology 1, Inc. Present in Europe in other categories	United States	VORTRAN-IPPB VORTRAN PercussiveNEB 2.0 VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port VORTRAN-IPPB with Manomter VORTRAN-IPPB with Water Trap VORTRAN PercussiveNEB	K003684 (2001)
Seoil Pacific Corp. Present in Europe in other categories	South Korea	Comfort Cough	K113549 (2013)
Advanced Bio Machines Pte. Ltd.	Singapore	–	registered
Amt Corp.	United States	–	registered
Baxter Healthcare Corp Present in Europe in other categories	United States	–	registered
CEVA Logistics Netherlands BV	Netherlands	–	registered
Flextronics International USA, Inc.	United States	–	registered
Hunan Ruijiong Biotech Co., Ltd.	China	–	K253001 (2026)
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.	Türkiye	–	registered
Mt. Olive Mfg., Co.	United States	–	registered
PLEXUS CORP.	United States	–	registered
Philips Medical Systems Nederland B.V. Present in Europe in other categories	Netherlands	–	registered
REACT HEALTH	United States	–	registered
VINCENT MEDICAL MANUFACTURING CO., LTD.	Hong Kong SAR China	–	registered

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