Apheresis devicesApheresis collection devices

Apheresis plasma collection devices

EMDN code B030101

9 manufacturers, 62 models including 62 on the market, 6 countries

On the market in 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
Nigale EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	DigiPla 8093/42 DigiPla 9093/42 P-1000B193/42 P-1000B293/42 P-300093/42 23 others P-300193/42 P-400493/42 P-400793/42 P-400993/42 P-401193/42 P-401393/42 P-401493/42 P-401793/42 P-401893/42 P-401993/42 P-402193/42 P-402393/42 P-402593/42 P-402693/42 P-402793/42 P-402893/42 P-411793/42 P-421793/42 P-500093/42 P-600093/42 P-600193/42 P-600593/42 P-600693/42	IIa, IIb 93/42	EUDAMED record Report an error
Haemonetics FDA EU representative : Haemonetics Italia s.r.l (Italy)	Switzerland, United States	0625Q-00 Plasma Bowl3 refs CONNECTOR, SPIKE/MALE LL HS PLS Bowl Persona Plasma Pooling Bottle Plasma Bottle3 refs PLS 2-Bags Closed Set, HS Bowl Plasma Collection Sets with HS bowl3 refs 6 others PLS 3-Bags Closed Sets, BMB Plasma Collection Sets with BMB bowl3 refs PLS 3-Product Bags Plasma Harness-out Sets2 refs PLS Bag Plasma Harness-out Sets3 refs PLS Bundled Set w/NaCL w/Vac Plasma Collection Sets with BMB bowl PLS Harness Set3 refs PLS HARNESS SET Plasma Harness Sets3 refs	IIa, IIb MDR	regulatoryeurope@haemonetics.com EUDAMED record Report an error
Meise	Germany	PB 1000 LLH B030101.IIa.XW93/42 PB 1000 LLH.1 B030101.IIa.XZ93/42 PB 1000 LLV B030101.IIa.XU93/42 PB 1000 SPH B030101.IIa.XX93/42 PB 1000 SPH.1 B030101.IIa.XY93/42 3 others PB 1000 SPV B030101.IIa.XV93/42 TF 1000.3 B030101.IIa.Xß93/42 TF 1000.5 B030101.IIa.Xß93/42	IIa 93/42	mail@meise.com EUDAMED record Report an error
Rev-Med FDA EU representative : Javitech Consulting GmbH (Germany)	South Korea	TriCell PRP Kit93/42 Tricell PRP L93/42 Tricell PRP Maxxi PRP93/42 TriCell PRP New93/42 TriCell PRP New S93/42	IIa 93/42	info@rev-med.co.kr EUDAMED record Report an error
Beijing Hanbaihan Medical Devices FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	HBH-(PRP Kit-08A,PRP Kit-08B, PRP Kit-08C, PRP Kit-08D, PRP Kit-10A, PRP Kit-10B,PRP Kit-10C,PRP Kit-10D,PRP Kit-12A,PRP Kit-12B,PRP Kit-12C,PRP Kit-12D,PRP Kit-20A,PRP Kit-20B,PRP Kit-20C,PRP Kit-20D,PRP Kit-30A,PRP Kit-30B,PRP Kit-30C,PRP Kit-30D)3 refs HBH-PRP Tube-05, HBH-PRP Tube-08, HBH-PRP Tube-10, HBH-PRP Tube-12, HBH-PRP Tube-20, HBH-PRP Tube-303 refs HBH-PRP Tube/N-05,HBH-PRP Tube/N -08,HBH-PRP Tube/N -10,HBH-PRP Tube/N -12,HBH-PRP Tube/N -20,HBH-PRP Tube/N -30, HBH-PRP Tube/F-05,HBH-PRP Tube/F-08,HBH-PRP Tube/F-10,HBH-PRP Tube/F-12,HBH-PRP Tube/F-20, HBH-PRP Tube/F-303 refs Kit/N-08A, Kit/N-08B,Kit/N-08C,Kit/N-08D,Kit/N-10A,Kit/N-10B,Kit/N-10C,Kit/N-10D,Kit/N-12A, Kit/N-12B, Kit/N-12C, Kit/N-12D, Kit/N-20A,Kit/N-20B, Kit/N-20C, Kit/N-20D, Kit/N-30A, Kit/N-30B, Kit/N-30C, Kit/N-30D (each model, "HBH-PRP" be added before it.)3 refs	IIa MDR	EUDAMED record Report an error
Haier Haematologi Chongqing EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Disposable Plasma Apheresis Sets FLQ/B1G1C1D13, FLQ/B1G1C1D3, FLQ/B1G1C1D15, FLQ/B1G1C1D14, FLQ/B1G1C1D1, FLQ/B1G1C1D12, FLQ/B1G1C1D11, FLQ/B1G1C1D2, FLQ/B1G1C1D21, FLQ/B1G1C1D22, FLQ/B1G1C1D23 Disposable Plasma Apheresis Sets FLQ/B1G1C1P13, FLQ/B1G1C1P3, FLQ/B1G1C1P15, FLQ/B1G1C1P14, FLQ/B1G1C1P1, FLQ/B1G1C1P12, FLQ/B1G1C1P11, FLQ/B1G1C1P2	IIb MDR	EUDAMED record Report an error
Mosvo EU representative : Eunitor GmbH (Germany)	China	Plasma Collection Systems BCS1593/42 Plasma Collection Systems BCS1693/42	IIb 93/42	Website EUDAMED record Report an error
B.T.I. Biotechnology Institute FDA	Spain	CENTRIFUGE	IIa MDR	EUDAMED record Report an error
Shenzhen Life Discover Medical System EU representative : SUNGO Europe B.V. (Netherlands)	China	Blood pressure cuff CM-1023S-053 refs	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) 11

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
Terumo BCT, INC. Present in Europe in other categories	United States	Trima Accel® Spectra Optia® COBE® Spectra COBE® 2991 Trima Accel® LRS® Rika Plasma Bottle	registered
Fresenius Kabi AG Present in Europe in other categories	Germany	AMICUS Separator AMICUS Separator Software AMICUS Separator Life Extension Software Aurora Xi Plasmapheresis System AMICUS Separator Legacy Software Aurora Xi	K200530 (2020)
FENWAL, INC.	–	ALYX™ 2RBC-LR Kit ALYX™ RBC/Plasma Kit ALYX 2RBC LR Kit with Saline Spike	registered
Comar LLC	United States	–	registered
Comar LLC / PCI	United States	–	registered
GVS TM, Inc.	United States	–	registered
Globus Medical, Inc. Present in Europe in other categories	United States	–	registered
JMS HEALTHCARE PHL, INC.	Philippines	–	registered
JMS SINGAPORE PTE. LTD Present in Europe in other categories	Singapore	–	registered
PLEXUS CORP.	United States	–	registered
Sanmina Corporation	United States	–	registered

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