Autotransfusion devices

EMDN code B04

9 manufacturers, 41 models including 40 on the market, 7 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 9

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
Eurosets FDA	Italy	ANTICOAGULANT LINE EU307793/42 CLEANFIELD 120Um-2800ML W/LINE93/42 CLEANFIELD 2800 ML W/FLOW REG.93/42 CLEANFIELD 2800ML W/LINE 3/8"93/42 FRESENIUS ORTHOPAS93/42 16 others GOCCIA FILTER 40Um93/42 GOCCIA FILTER 40Um W/LINE2 refs93/42 LINEA ASPIRAZIONE ANTICOAG. I93/42 ORTHOPAS DRY WASH SET93/42 ORTHOPAS DRY WASH UNIT93/42 ORTHOPAS DRY WASH W/SUCT.PUMP93/42 ORTHOPAS SET93/42 OrthoPAS SET w/suction pump93/42 ORTHOPAS UNIT93/42 ORTHOPAS W/REINFUSION BAG93/42 QUALITY SENSOR DRY WASH93/42 ROME Chest Drain PAS93/42 ROME Chest Drain PAS CUSTOM93/42 VENICE Chest Drain PAS93/42 VENICE Chest Drain PAS w/conn.93/42 VENICE PAS SET W/2x1/4" CONN.93/42	IIa 93/42	Website EUDAMED record Report an error
Primed Halberstadt Medizintechnik	Germany	PRIAUTOTRANS Set für postoperative Autotransfusion mit 2 Anschlüssen, Blutsammelbeutel 700 ml, Blutfilter 175/40 µm Autologe Autotransfusionssets93/42 PRIAUTOTRANS Set für postoperative Autotransfusion mit 3 Anschlüssen, Blutsammelbeutel 700 ml, 2x Redondrain mit Trokar Ch10/800/150 mm Autologe Autotransfusionssets93/42 Set für postoperative Autotransfusion 1-fach mit Ersatzbeutel und Drain mit Trokar (Ch.14) Autologe Autotransfusionssets93/42 Set für postoperative Autotransfusion 40 µm Filter - 1 Anschluss geschlossen, Blutsammelbeutel 1000ml und Drain und Trokar Ch.18/ 800/150 Autologe Autotransfusionssets93/42 Set für postoperative Autotransfusion mit Ersatzbeutel und Drain mit Trokar (Ch.14) Autologe Autotransfusionssets93/42 1 other Set für postoperative Autotransfusion, mit Ersatzbeutel und Drain mit Trokar (Ch.16) Autologe Autotransfusionssets93/42	IIa 93/42	Website EUDAMED record Report an error
Redax FDA	Italy	ATS Bulb Set con Redon CH 12 ATS Bulb Set – medio vuoto con linea estensione - CH 163 refs ATS Bulb Set – medio vuoto con linea estensione - CH 1493/42 ATS Bulb Set – medio vuoto con Redon c/ago CH 1493/42 ATS Bulb Set – Medio vuoto con Redon CH 1493/42 Drentech Emotrans Dune per autotrasfusione93/42	IIa MDR, 93/42	EUDAMED record Report an error
Brightwake FDA EU representative : CS Life Sciences Europe Ltd (Ireland)	United Kingdom (ex Northern Ireland)	Hemosep Cell Concentrator Pack93/42 Hemosep Intra-Operative Kit93/42 Hemosep Suction Kit93/42	IIa, IIb 93/42	Website ra@brightwake.co.uk EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands)	United States	autoLog IQ™2 refs Wash Kit93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Medical2Market	Netherlands	HemoClear HC01K	IIb MDR	Website info@medical2market.com EUDAMED record Report an error
Sorin Group Italia FDA	Italy	XTRA9 refs	IIa, IIb MDR	EUDAMED record Report an error
Ycellbio FDA EU representative : KTR Europe GmbH (Germany)	South Korea	Sterile PRP Blood Separation Kit YCELLBIO-KIT	IIa MDR	info@ycellbio.com EUDAMED record Report an error
Beijing Jingjing Medical Equipment EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Blood-Processing Autotransfusion Systems 3000NE93/42 (no longer marketed)	IIb 93/42	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) 38

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
TELEFLEX INCORPORATED Present in Europe in other categories	United States	PLEUR-EVAC PLEUR EVAC	registered
LIVANOVA USA, INC. Present in Europe in other categories	Germany	BRAT Accessory Orthofuser Drain Line Crit-Line Cuvette XVAC XTRA	registered
Terumo Cardiovascular Systems Corporation	United States	Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir Capiox® Flexible Venous Reservoir NX19 Oxygenator w/4-liter reservoir; left-side outlet port NX19 Oxygenator w/4-liter reservoir; right-side outlet port	K153143 (2015)
Fresenius Kabi AG Present in Europe in other categories	Germany	ATF 120 Fast Start Kit ATY Y-Adapter ATO Oxygenator line ATV-F140C Vacuum Lines Combi-pack AT1 Autotransfusion Set ATV-180 Vacuum Line	K210089 (2021)
3t Medical Systems, LLC	United States	CBCII ConstaVac ConstaVac CBC II Constavac CBC III Constavac CBCII Ambulating Bulb	registered
Avanos Medical, Inc.	United States	PROLONG* Continuous Nerve Block Set PROLONG* Continuous Nerve Block Set with NRFit™ Connector	registered
Davol, Inc.	United States	SURETRANS	K931899 (1994)
Circulatory Technology, Inc.	United States	Bigger Better-Bladder Better-Bladder	K140321 (2014)
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.	United States	H.A.S.®	registered
Allied Medical, LLC Present in Europe in other categories	United States	PC	registered
GLOBAL BLOOD RESOURCES LLC	United States	Global Blood Resources	K031150 (2003)
Inquis Medical, Inc.	United States	Aventus Thrombectomy System - Clot Management System	K240426 (2024)
Procell Surgical (us) Inc.	Canada	ProCell Surgical Sponge-Blood Recovery Unit	K193361 (2020)
Spectrum Medical , Ltd. Present in Europe in other categories	United Kingdom	Quantum Perfusion Hybrid System	K241206 (2024)
TERUMO CORPORATION Present in Europe in other categories	United States	CAPIOX	K030449 (2003)
Amphenol Critical Medical Technologies, LLC	United States	–	registered
Atrium Medical Corp.	United States	–	K201305 (2021)
Bioprod d.o.o.	Slovenia	–	registered
DSV Contract Logistics	Mexico	–	registered
Flextronics International USA, Inc.	United States	–	registered
Globus Medical, Inc. Present in Europe in other categories	United States	–	registered
Kluge Design LLC	United States	–	registered
Lotus US Bidco Inc.	United States	–	registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories	United States	–	registered
MULTISOURCE MANUFACTURING LLC	United States	–	registered
Medtronic Cardiac Surgery	United States	–	K241053 (2024)
Medtronic Perfusion Systems	United States	–	K181954 (2018)
Miller Technical Services	United States	–	registered
NOVOSCI CORP.	United States	–	registered
PLEXUS CORP.	United States	–	registered
Robling Medical, LLC	United States	–	registered
Rommelag CDMO GmbH	Germany	–	registered
SB-KAWASUMI LABORATORIES, INC. Present in Europe in other categories	Japan	–	registered
STRYKER CORPORATION Present in Europe in other categories	United States	–	K914053 (1992)
Sanmina Corporation	United States	–	registered
Sisu Global Health	United States	–	K210862 (2021)
Southmedic, Inc.	Canada	–	registered
Terumo Medical Corp. Present in Europe in other categories	United States	–	K991973 (1999)

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