IVD instrumentsHematology / histology / cytology instruments

Flow cytometry instruments

EMDN code W020204

9 manufacturers, 21 models including 21 on the market, 4 countries

On the market in 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
Challenbio EU representative : MedPath GmbH (Germany)	China	Cytosteller DX02 Cytosteller DX01 Cytosteller DX03 Cytosteller DX04 Cytosteller DX05 8 others Cytosteller DX06 Cytosteller DX07 Cytosteller DX08 Flow Cytometer6 refs Flow Cytometer CytoStellar AX01 Flow Cytometer CytoStellar AX02 Flow Cytometer CytoStellar AX03 Flow Cytometer CytoStellar AX04	A IVDR	sale@challenbio.com EUDAMED record Report an error
Bdbiosciences FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	BD FACSLYRIC3 refs	A IVDR	Website EUDAMEDenquiries@bd.com EUDAMED record Report an error
Beckman Coulter FDA	Ireland	AQUIOS CL Flow Cytometer2 refs	A IVDR	Website ra.clare@beckman.com EUDAMED record Report an error
Cytekbio EU representative : Emergo Europe B.V. (Netherlands)	United States	Northern Lights™-CLC NL-CLC3 refs	A IVDR	Website EUDAMED record Report an error
Joinstar EU representative : Medunion S.L. (Spain)	China	iMatrix Prime	A IVDR	EUDAMED record Report an error
Shanghai Nokayun Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	Lymacyte（V-B-Y-R）、Lymacyte（V-B-Y）、Lymacyte（B-Y-R）、Lymacyte（V-B-R）、Lymacyte（V-B）、Lymacyte（B-Y）、Lymacyte（B-R）、Lymacyte（B）3 refs	A IVDR	EUDAMED record Report an error
Singlecellbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	FlowRACS HT300 Univ	A IVDR	EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany)	Japan	Flow Cytometer XF-1600	A IVDR	ra_archive@sysmex.co.jp EUDAMED record Report an error
Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	BF-730 B4 Flow Cytometer BF-730 B5R3V6、BF-730 B5R3V5、BF-730 B4R3V3、BF-730 B5R3、BF-730 B5R2、BF-730 B4R2、BF-730 B5、BF-730 B4、BF-700 B3R1、BF-700 B4、BF-700 B4R1、BF-700 B5、BF-700 B4R2、BF-700 B5R2、BF-700 B5R3、BF-710 B5R3、BF-710 B5R2、BF-710 B5 etc.	A IVDR	Website service@uritest.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) 5

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
Becton, Dickinson & CO Present in Europe in other categories	United States	FACSCanto BD FACSuite FACS BD FACSLyric BD Multitest	K201814 (2020)
Boule Diagnostics AB Present in Europe in other categories	Sweden	–	registered
Flextronics International USA, Inc.	United States	–	registered
STRATEC SE Present in Europe in other categories	Germany	–	registered
STRATEC Switzerland AG c/o STRATEC SE	Germany	–	registered

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