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Emdyca

IVD instruments

Hematology / histology / cytology instruments

EMDN code W0202

274 manufacturers, 1,157 models including 1,135 on the market, 29 countries

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Manufacturers registered in Europe (EUDAMED) 274
  • 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
Dymind EU representative : Eunitor GmbH (Germany) China
42 others
 A, B IVDR, 98/79 regulationdept@dymind.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
32 others
 A, B IVDR, 98/79 Website support@rayto.com EUDAMED record Report an error
Amos Scientific Pty EU representative : Luxus Lebenswelt GmbH (Germany) Australia
27 others
 A IVDR info@amos-scientific.com EUDAMED record Report an error
Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands) and 1 other Australia, Germany, United States
27 others
 A IVDR Website support.de@LeicaBiosystems.com EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany) Japan
22 others
 A IVDR, 98/79 ra_archive@sysmex.co.jp EUDAMED record Report an error
Genegeo EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
17 others
 A IVDR, 98/79 sales@genegeo.com EUDAMED record Report an error
E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
16 others
 A IVDR, 98/79 EUDAMED record Report an error
Horiba FDA France
16 others
 A, B IVDR, 98/79 EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
15 others
 A, B IVDR, 98/79 Website EUDAMED record Report an error
Shandon Diagnostics FDA EU representative : Epredia Netherlands B.V. (Netherlands) United Kingdom (ex Northern Ireland)
15 others
 A IVDR EUDAMED record Report an error
Evident FDA EU representative : Evident Europe GmbH (Germany) Japan
12 others
 A IVDR EUDAMED record Report an error
Urit FDA EU representative : Medunion S.L. (Spain) and 1 other China
12 others
 A, B IVDR, 98/79 Website service@uritest.com EUDAMED record Report an error
Iline Microsystems FDA Spain
11 others
 A IVDR, 98/79 eudamed@ilinemicrosystems.com EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy) United States
11 others
 A IVDR Website Regulatory@werfen.com EUDAMED record Report an error
Optika Microscopes Italy
11 others
 A IVDR EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other China
9 others
 A IVDR, 98/79 EUDAMED record Report an error
Especialidades Médicas Myr FDA Spain
9 others
 A IVDR Website EUDAMED record Report an error
Challenbio EU representative : MedPath GmbH (Germany) China
8 others
 A IVDR sale@challenbio.com EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands) and 1 other China
8 others
 A, B IVDR, 98/79 Website EUDAMED record Report an error
Sunbiote EU representative : Lotus NL B.V. (Netherlands) China
8 others
 A IVDR Website EUDAMED record Report an error
Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other China
7 others
 A IVDR info@infitek.com EUDAMED record Report an error
Leica Microsystems CMS FDA Germany
7 others
 A IVDR EUDAMED record Report an error
Human Germany
6 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Sakura Seiki EU representative : Sakura Finetek Europe B.V. (Netherlands) Japan
6 others
 A IVDR Website EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) Ireland, United States
5 others
 A IVDR, 98/79 Website ra.clare@beckman.com EUDAMED record Report an error
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China
5 others
 A, B IVDR, 98/79 Website service@genrui-bio.com EUDAMED record Report an error
Linear FDA Spain
5 others
 A IVDR Website info@linear.es EUDAMED record Report an error
Medite FDA Germany
5 others
 A IVDR Website EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China
5 others
 – 98/79 EUDAMED record Report an error
Slee FDA Germany
5 others
 A IVDR EUDAMED record Report an error
Zybio FDA EU representative : QbD RepS BV (Belgium) China
5 others
 A, B IVDR PMS@zy-ivd.com EUDAMED record Report an error
Diagon Hungary
4 others
 A IVDR Website EUDAMED record Report an error
pfm medical FDA Germany
4 others
 A IVDR Website info@pfmmedical.com EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
 B IVDR, 98/79 EUDAMED record Report an error
Erba Czechia
3 others
 A, B IVDR Website EUDAMED record Report an error
Milestone FDA Italy
3 others
 A IVDR Website marketing@milestonemedsrl.com EUDAMED record Report an error
Wheisman Medical Technology EU representative : Umedwings Netherlands B.V. (Netherlands) China
3 others
 – 98/79 EUDAMED record Report an error
3Dhistech Hungary
2 others
 A IVDR Website info@3dhistech.com EUDAMED record Report an error
Bio-Optica Milano FDA Italy
2 others
 A IVDR Website info@bio-optica.it EUDAMED record Report an error
Diapath FDA Italy
2 others
 A IVDR Website info@diapath.com EUDAMED record Report an error
Hunan Ehome Health Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
2 others
 A IVDR, 98/79 EUDAMED record Report an error
Opta-Tech Poland
2 others
 A IVDR Website EUDAMED record Report an error
Zeiss FDA EU representative : Carl Zeiss Microscopy GmbH (Germany) China, Germany
2 others
 A IVDR Website regulatoryaffairs.microscopy@zeiss.com EUDAMED record Report an error
Accriva Diagnostics FDA EU representative : MDSS GmbH (Germany) United States
1 other
 A IVDR Website EUDAMED record Report an error
Dakewe FDA EU representative : SUNGO Europe B.V. (Netherlands) China
1 other
 A IVDR Website EUDAMED record Report an error
Dartmon FDA EU representative : R Sight B.V. (Netherlands) and 1 other China
1 other
 A IVDR Website EUDAMED record Report an error
Gmt Sarl France
1 other
 A IVDR, 98/79 Website EUDAMED record Report an error
Intelsint Italy
1 other
 A IVDR Website info@intelsint.com EUDAMED record Report an error
Pro-med (Beijing) Technology EU representative : Sungo Cert GmbH (Germany) China
1 other
 A IVDR, 98/79 EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) China
1 other
 A IVDR, 98/79 Website service@reetoo.com.cn EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China
1 other
 – 98/79 Website info@szyhlo.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States
1 other
 A, B IVDR, 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
Weinkauf Medizintechnik Germany
1 other
 A IVDR Website info@weinkauf-medizintechnik.de EUDAMED record Report an error
Micro Instrument EU representative : CMC Medical Devices & Drugs SL (Spain) India
1 other
 I, A IVDR, MDR Website info@mikoindia.com EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark) Singapore A IVDR Website info.dk@agilent.com EUDAMED record Report an error
Diatron FDA Hungary A IVDR Website EUDAMED record Report an error
Drucker Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website regulatory@druckerdiagnostics.com EUDAMED record Report an error
Euromex Netherlands A IVDR Website info@euromex.com EUDAMED record Report an error
Hamamatsu EU representative : Hamamatsu Photonics Deutschland GmbH (Germany) Japan A IVDR Website sales@sys.hpk.co.jp EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands) China A IVDR Website info@medcaptain.com EUDAMED record Report an error
Rrmechatronics FDA Netherlands A IVDR Website support@rrmechatronics.com EUDAMED record Report an error
Seamaty EU representative : GRZAN GmbH (Germany) and 1 other China A IVDR EUDAMED record Report an error
Strumed FDA EU representative : Amstermed B.V. (Netherlands) India – 98/79 Website EUDAMED record Report an error
Translite FDA EU representative : E C REP LIMITED (Ireland) United States I 93/42 Website info@veinlite.com EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 sales@ukinbio.com EUDAMED record Report an error
Grundium Finland A IVDR Website support@grundium.com EUDAMED record Report an error
"Bio-Ksel" Poland A IVDR Website EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) United States A, B IVDR Website EUDAMED record Report an error
Behnk Germany A IVDR Website regulatory@behnk.de EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Changchun Chenyu Taikang Medical Laboratory EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Grifols FDA Spain A IVDR regulatoryaffairs_dxbu@grifols.com EUDAMED record Report an error
Guangzhou Xiuwei Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China A IVDR Website EUDAMED record Report an error
Hangzhou HealthSky Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Huron Technologies International EU representative : 4 Easy Prrc 2 Smart Mdr, Lda (Portugal) Canada A IVDR Website regulatory@hurondigitalpathology.com EUDAMED record Report an error
Jinquanmedical EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR sales1@jinquanmedical.com EUDAMED record Report an error
Kaltek Italy A IVDR info@kaltek.it EUDAMED record Report an error
Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) China A IVDR, 98/79 EUDAMED record Report an error
Motic FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary A IVDR EUDAMED record Report an error
Objective Imaging EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Orphée EU representative : PZ CORMAY Spółka Akcyjna (Poland) Switzerland – 98/79 ra@orphee-medical.com EUDAMED record Report an error
Ral Tecnica Para El Laboratorio Spain A IVDR Website EUDAMED record Report an error
Shanghai LeChen Biotechnology EU representative : Everbiz GmbH (Austria) China A IVDR EUDAMED record Report an error
Shanghai THAN Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen Channel Biotechnology EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 Website service.channel@szchenna.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA Germany A IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Sistat Türkiye A IVDR Website info@sistat.com.tr EUDAMED record Report an error
Spinreact Spain – 98/79 Website EUDAMED record Report an error
SysCan MedTech (Suzhou) EU representative : Obelis s.a. (Belgium) China A IVDR EUDAMED record Report an error
Visia Lab FDA Italy A IVDR, 98/79 Website quality@visialab.com EUDAMED record Report an error
Xiaogan Kuohai Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Aikang MedTech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Alcor Scientific FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR EUDAMED record Report an error
BotuAImaging Technology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Cellomics (Shenzhen) EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Diesse FDA Italy A, B IVDR Website EUDAMED record Report an error
Euroimmun FDA Germany A IVDR Website info@euroimmun.de EUDAMED record Report an error
Guangzhou Naturn Medical Devices EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Haemokinesis EU representative : Compliance Management Solutions Europe LTD (Bulgaria) Australia A IVDR, 98/79 EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States A, C IVDR EUDAMED record Report an error
Immucor FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany) Germany, United States A IVDR Website regulatoryimmucor@werfen.com EUDAMED record Report an error
Islandpolymer Germany A IVDR Website EUDAMED record Report an error
Jokoh EU representative : MDSS GmbH (Germany) Japan – 98/79 Website EUDAMED record Report an error
Meril Diagnostics FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other India A IVDR Website ram.kanoje@merillife.com EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website eudamed@nanoentek.com EUDAMED record Report an error
Ningbo Chiwell Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
RAL Diagnostics FDA France A IVDR Website info@ral-diagnostics.fr EUDAMED record Report an error
Renderbio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Sakura Finetek USA EU representative : Sakura Finetek Europe B.V. (Netherlands) United States A IVDR PRRC@sakuraus.com EUDAMED record Report an error
Shenyang Kingpel Biotech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Tridema Italy A IVDR Website EUDAMED record Report an error
Wuhan Landing Intelligence Medical FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
ZKYH AImed Technology （Guangxi） EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
ZOVEC diagnostics Germany – 98/79 Website EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) China A IVDR EUDAMED record Report an error
Boule FDA Sweden B IVDR Website info@boule.com EUDAMED record Report an error
CoaguSense FDA EU representative : Emergo Europe B.V. (Netherlands) United States A, C IVDR Website EUDAMED record Report an error
Conlett EU representative : Lotus NL B.V. (Netherlands) China I MDR EUDAMED record Report an error
CooperSurgical FDA EU representative : CooperSurgical Distribution B.V. (Netherlands) United States I MDR RA-CSI@coopersurgical.com EUDAMED record Report an error
Dagatron FDA EU representative : BZT-TCP Certification GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 office@guoke-medical.com EUDAMED record Report an error
Diagnostic BioSystems FDA EU representative : MedEnvoy Global BV (Netherlands) United States A IVDR EUDAMED record Report an error
Diagnostics Belgium A IVDR, 98/79 Website EUDAMED record Report an error
EFA Engineering for All EU representative : MedNet EC-REP GmbH (Germany) Israel – 98/79 Website EUDAMED record Report an error
Essenlix EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR Website info@essenlix.com.cn EUDAMED record Report an error
Guangzhou Hearty Expression Medical Technology EU representative : Everbiz GmbH (Germany) China A IVDR EUDAMED record Report an error
High Technology FDA EU representative : MedEnvoy Global BV (Netherlands) United States A IVDR Website EUDAMED record Report an error
Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 EUDAMED record Report an error
Labex Canada EU representative : Obelis s.a. (Belgium) Canada A IVDR Website info@labexcanada.com EUDAMED record Report an error
Labitec Germany A IVDR EUDAMED record Report an error
Lordsmark EU representative : Obelis s.a. (Belgium) India A IVDR Website EUDAMED record Report an error
Lumatas FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
Medical Devices EU representative : Obelis s.a. (Belgium) Pakistan I MDR Website EUDAMED record Report an error
Microprofit EU representative : MedNet EC-REP GmbH (Germany) China A IVDR EUDAMED record Report an error
Nantong Mevid Life Scientific EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Neotech Products FDA EU representative : Emergo Europe B.V. (Netherlands) United States I MDR Website ra@neotechproducts.com EUDAMED record Report an error
Nev Yazilim Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye A IVDR info@nevasoftai.com EUDAMED record Report an error
NTP Nano Tech Projects FDA Italy A IVDR info@ntpsrl.biz EUDAMED record Report an error
OptraSCAN FDA EU representative : AR Experts B.V. (Netherlands) United States A IVDR Website info@optrascan.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Raritan EU representative : Ortho-Clinical Diagnostics France (France) United States A IVDR Website PRRC@quidelortho.com EUDAMED record Report an error
Philips FDA Netherlands A IVDR eudamed@philips.com EUDAMED record Report an error
Poweam EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Roche FDA Germany C IVDR, 98/79 Website EUDAMED record Report an error
Samantree FDA EU representative : SamanTree Medical France SASU (France) Belgium, Switzerland I, A IVDR, MDR Website info@samantree.com EUDAMED record Report an error
Sclavo Italy A IVDR, 98/79 qa@sclavo.it EUDAMED record Report an error
Seekxbio EU representative : GRZAN GROUP SL (Spain) China A IVDR EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Shanghai Howsome Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen YC Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website sales@szzijian.com EUDAMED record Report an error
Sidena France A IVDR info@sidena.com EUDAMED record Report an error
Singlecellbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Suzhou Ruiqian Technologies EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Technoclone Austria A IVDR Website regulatory@technoclone.com EUDAMED record Report an error
TECO Medical Instruments, Production + Trading Germany A IVDR Website info@teco-medical.com EUDAMED record Report an error
Tem Innovations FDA Germany A IVDR EUDAMED record Report an error
Tianjin Dexiang Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium) China A IVDR Website sales@wondfo.com.cn EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website info@wwhsbio.com EUDAMED record Report an error
Zonci EU representative : MedNet EC-REP GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Greiner Bio-One Austria A IVDR Website regulatory-affairs.at@gbo.com EUDAMED record Report an error
ABI Enterprises EU representative : CMC Medical Devices & Drugs SL (Spain) Pakistan I MDR EUDAMED record Report an error
ABW Medizin und Technik Germany A IVDR Website info@abw-medizintechnik.de EUDAMED record Report an error
Alifax FDA Italy A IVDR Website regulatory@alifax.com EUDAMED record Report an error
Aquisel FDA Spain A IVDR EUDAMED record Report an error
Arteion France B IVDR contact@arteion.com EUDAMED record Report an error
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Avecon Healthcare EU representative : Amstermed B.V. (Netherlands) India A IVDR Website EUDAMED record Report an error
B.P.C. Biosed – Italy A IVDR Website info@bpcbiosed.it EUDAMED record Report an error
BaSO Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) Taiwan A IVDR Website services@basobiotech.com EUDAMED record Report an error
Baso Diagnostics Zhuhai EU representative : Eunitor GmbH (Germany) China A IVDR EUDAMED record Report an error
Bdbiosciences FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States A IVDR Website EUDAMEDenquiries@bd.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States A IVDR Website EUDAMED record Report an error
Beijing High-Grade Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR admin@biohighgrade.com EUDAMED record Report an error
Bensrl Italy A IVDR Website EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Biolabo France A IVDR support@biolabo.fr EUDAMED record Report an error
Biosense EU representative : MD&D Alliance GmbH (Germany) India A IVDR regulatory.affairs@biosense.in EUDAMED record Report an error
Biosystems FDA Spain A IVDR Website EUDAMED record Report an error
BioView FDA EU representative : MedNet EC-REP GmbH (Germany) Israel A IVDR Website info@bioview.co.il EUDAMED record Report an error
Biyosistem Türkiye A IVDR Website info@biyosistem.com.tr EUDAMED record Report an error
Bndhematech EU representative : Umedwings Netherlands B.V. (Netherlands) China I MDR marketing@bndhematech.com EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea A IVDR Website marketing@boditech.co.kr EUDAMED record Report an error
Changsha Han Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Chongqing NanFang Numerical ControlEquipment EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Chubio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Cision Vision FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) United States A IVDR EUDAMED record Report an error
CompAI MedTech (Dalian) EU representative : Debao International GmbH (Germany) China A IVDR ra@comp-ai.com EUDAMED record Report an error
Cytekbio EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
Cytochipinc FDA EU representative : Medunion S.L. (Spain) United States A IVDR quality@cytochipinc.com EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Dainippon Seiki FDA EU representative : MedNet EC-REP GmbH (Germany) Japan A IVDR Website EUDAMED record Report an error
Datexim France – 98/79 Website contact@datexim.com EUDAMED record Report an error
Diagast FDA France A IVDR Website contact@diagast.com EUDAMED record Report an error
Disera Türkiye A IVDR EUDAMED record Report an error
Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş Türkiye A IVDR EUDAMED record Report an error
EKF-diagnostic FDA Germany B IVDR info@ekf-diagnostic.de EUDAMED record Report an error
Elmontsrl Italy A IVDR Website EUDAMED record Report an error
Evident Technology Center Europe Germany A IVDR Website EUDAMED record Report an error
Evidentscientific EU representative : Evident Europe GmbH (Germany) United States A IVDR Website EUDAMED record Report an error
Excilone France A IVDR Website EUDAMED record Report an error
FFEI EU representative : Eurolink Europe Compliance Limited (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website regulatory@ffei.co.uk EUDAMED record Report an error
Flash Pathology Netherlands A IVDR Website info@flashpathology.com EUDAMED record Report an error
Guangzhou Improve Medical Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR ra@improve-medical.com EUDAMED record Report an error
Haemonetics FDA EU representative : Haemonetics Italia s.r.l (Italy) Switzerland A IVDR regulatoryeurope@haemonetics.com EUDAMED record Report an error
Haimen Rotest Labware Manufacturing EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR export@hmrotest.com EUDAMED record Report an error
Haimen Shengbang Laboratory Equipment FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hangzhou PathoAl Technology EU representative : BioDomi GmbH (Germany) China A IVDR EUDAMED record Report an error
Hangzhou Yipai Intelligent Technology EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Helixgen (GUANGZHOU) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 EUDAMED record Report an error
HemoCue FDA Sweden A IVDR Website info@hemocue.se EUDAMED record Report an error
Hemonart Türkiye – 98/79 Website info@hemonart.com EUDAMED record Report an error
Hospitex Italy A IVDR Website info@hospitex.com EUDAMED record Report an error
Hrjbio EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website info@hrjbio.com EUDAMED record Report an error
Huchuang FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Imedikers EU representative : Veritas Eston OÜ (Estonia) South Korea A IVDR info@veritaseston.eu EUDAMED record Report an error
Inpeco FDA EU representative : QbD RepS BV (Belgium) Switzerland A IVDR Regulatory.Affairs@inpeco.com EUDAMED record Report an error
International Biomedical FDA EU representative : Emergo Europe B.V. (Netherlands) United States I MDR Website regulatory@int-bio.com EUDAMED record Report an error
Invenio Imaging FDA EU representative : QbD RepS BV (Belgium) United States A IVDR Website contact@invenio-imaging.com EUDAMED record Report an error
Jiangsu Kahotest Citotest Labware Manufacturing EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Jiangsu Kangjie Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Joinstar EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Konan FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Japan A IVDR Website EUDAMED record Report an error
Labpathexperts Poland I MDR Website office@labpathexperts.com EUDAMED record Report an error
Langenbrinck Germany A IVDR EUDAMED record Report an error
Longlight Technology EU representative : GRZAN GROUP SL (Spain) China A IVDR marketing@longlightech.com EUDAMED record Report an error
Morphlelabs FDA EU representative : Amstermed B.V. (Netherlands) India A IVDR sales@morphlelabs.com EUDAMED record Report an error
Möller Medical FDA Germany I MDR Website info@moeller-medical.com EUDAMED record Report an error
Nanjing Superfit I & E EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Nantong Huayun Medical Equipment Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Newmars Technologies Kft Hungary IIa 93/42 EUDAMED record Report an error
Nikon FDA EU representative : Nikon Europe B.V. (Netherlands) Japan A IVDR Regulatory.Affairs@nikon.com EUDAMED record Report an error
Ningbo Greetmed Medical Instruments FDA EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
Ningbo MedicalSystem Biotechnology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Noul FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website cs@noul.com EUDAMED record Report an error
Ortho-Clinical Diagnostics FDA EU representative : Ortho-Clinical Diagnostics France (France) United Kingdom (ex Northern Ireland) A IVDR Website PRRC@quidelortho.com EUDAMED record Report an error
Pathcom Systems FDA EU representative : Hab Gov Strategics Applied Technologies Limited (Malta) United States A IVDR Website info@pathcomx.com EUDAMED record Report an error
Pixcell Medical FDA EU representative : AR Experts B.V. (Netherlands) Israel B IVDR Website info@picxell-medical.com EUDAMED record Report an error
PreciPoint Germany A IVDR Website info@precipoint.de EUDAMED record Report an error
Pushkang EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
RWD Life Science FDA EU representative : WISELINK MEDICAL, S.L.U. (Spain) China A IVDR Website EUDAMED record Report an error
Sanymed Italy A IVDR Website info@sanymed.it EUDAMED record Report an error
Sarstedt FDA Germany A IVDR Website EUDAMED record Report an error
Seleo Italy – 98/79 Website EUDAMED record Report an error
Shanghai Nokayun Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen Cinnaray Life Technology EU representative : HUMISS TRADING S. L. (Spain) China A IVDR EUDAMED record Report an error
Shenzhen CoooSeee Biomedical EU representative : MedNet EC-REP GmbH (Germany) China B IVDR service@comenbio.com EUDAMED record Report an error
Shenzhen Landwind Biomedical Technology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 sales@landwindmedical.com EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR Website EUDAMED record Report an error
Shenzhen Tiantong Diagnostic Technology EU representative : GRZAN GmbH (Germany) China A IVDR EUDAMED record Report an error
ShijiYiKang (Tianjin) Medical Technology Development EU representative : HUMISS TRADING S. L. (Spain) China A IVDR EUDAMED record Report an error
Shinwha Medi EU representative : Advena Limited (Malta) South Korea A IVDR Website EUDAMED record Report an error
Sinobiocan EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Stago FDA France A IVDR EUDAMED record Report an error
Sterile Safequip Chemicals FDA EU representative : CMC Medical Devices & Drugs SL (Spain) India A IVDR Website EUDAMED record Report an error
Stratipath Sweden – 98/79 Website info@stratipath.com EUDAMED record Report an error
Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Tcoag FDA Ireland – 98/79 Website EUDAMED record Report an error
Tharmac Germany A IVDR Website info@tharmac.de EUDAMED record Report an error
Thermogenesis FDA EU representative : MDSS GmbH (Germany) United States IIa MDR Website regulatoryaffairs@thermogenesis.com EUDAMED record Report an error
Weihai Sunway Medical Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China I MDR EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Argentina A IVDR Website marketing@wiener-lab.com EUDAMED record Report an error
Wuhan Heer Medical Technology Development EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Wuzhou Aokace Technology EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Yancheng Huida Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
YD Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website admin@yd-diagnostics.com EUDAMED record Report an error
Zhongshan Chuangyi Biochemical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Xpenarray EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market China
3 others
 – 98/79 EUDAMED record Report an error
Zhuhai DL Biotech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) No model still on the market China A IVDR Website EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market Egypt – 98/79 Website info@nsbiotec.com EUDAMED record Report an error
S.D. Sight Diagnostics FDA EU representative : CEpartner4U (Netherlands) No model still on the market Israel – 98/79 Website info@sightdx.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) 252

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
CAPlugs Present in Europe in other categories United States Caplugs/Evergreen registered
Andwin Scientific United States Andwin Scientific Papette Andwin Rovers Safetex K983599 (1998)
ELITECHGROUP INC. Present in Europe in other categories United States Excyte 20 Excyte® ESR Vacuum Tube, Carton Monosed® ESR Vacuum Tubes, Carton Excyte® ESR Vacuum Tube Excyte Excyte® ESR Vacuum Tubes registered
Bio-Rad Medical Diagnostics GmbH Present in Europe in other categories – MLB 2 IH-Card Neutral Alsevers Solution Bromelin for Erytype TANGO infinity IH-1000 registered
Rovers Medical Devices B.V. United States Rovers® Cervex-Brush® Rovers® Cervex-Brush® Combi Rovers® EndoCervex-Brush® Rovers® Viba-Brush® Rovers® Cervex-Brush® RT Rovers® EndoCervex-Brush®-S RT K043369 (2005)
SAKURA FINETEK U.S.A., INC. Present in Europe in other categories United States Tissue-Tek® TEC™ 6 Tissue-Tek AutoTEC® a120 Tissue-Tek Xpress® Tissue-Tek VIP® Tissue-Tek VIP® 6 Tissue-VIP® 6 AI K881165 (1988)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC. – Research and Diagnostic Systems registered
Helena Laboratories United States Cascade M-4 (110V/220V) Helena Ristocetin Plateletworks Collagen Kit Plateletworks Combo-10 Kit Plateletworks Combo-25 Kit Plateletworks ADP Kit K061014 (2006)
Mechatronics USA LLC – Starrsed registered
Eldon Biologicals A/S Present in Europe in other categories Denmark ELDON SCHOOL KIT SK 2511-30 ELDON SCHOOL KIT SKA 2521-25 ELDON SCHOOL KIT SKA 2511-30 ELDON HOME KIT HKA 2511-1 DOCTOR'S KIT DKS RhD-25 ELDON MILITARY KIT MKA 2521-25 registered
RUSHABH INSTRUMENTS, LLC United States HistoPro® registered
BIOCARE MEDICAL LLC Present in Europe in other categories – intelliPATH MAX intelliPATH Plus Decloaking Chamber™ NxGen Decloaking Chamber™ NxGen Reconditioned intelliPATH FLX Automated Slide Staining System registered
AccuTec, Inc. United States AccuThrive® registered
Dakewe (Shenzhen) Medical Equipment Co., Ltd. China MT1 Rotary Microtome CT520 Cryostat Microtome CT620 Cryostat Microtome 6250 Cryostat Microtome HP300Plus Automatic Tissue Processor HP-HUGO Automatic Tissue Processor registered
Medtronic, Inc. Present in Europe in other categories United States CLOTtrac™ RACT CLOTtrac® HEPtrac® HEPline® registered
bioMerieux, Inc. Present in Europe in other categories United States PREVI® COLOR SINGLE SAMPLE CHAMBERS FAST (WHITE) PREVI® COLOR GRAM V2 PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE PREVI® COLOR POLY-L-LYSINE SLIDES DUAL PREVI® COLOR SINGLE SAMPLE CHAMBERS SLOW (TAN) PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN) registered
Welch Allyn, Inc. Present in Europe in other categories United States Welch Allyn, Inc. registered
R & D Batteries, Inc. United States R&D Batteries, Inc. K934747 (1993)
SIENCO, INC. United States Sonoclot® SonACT Kit Sonoclot® kACT Kit Sonoclot® NonActivated Kit Sonoclot® Reference Viscosity Oil Quality Control Kit Sonoclot® Reference Plasma Quality Control Kit K260909 (2026)
FEATHER SAFETY RAZOR CO., LTD. Present in Europe in other categories Japan FEATHER MICROTOME BLADE registered
Scopio Labs , Ltd. Present in Europe in other categories Israel X100 Digital Scanner X100 Processing Unit (Complete Unit) X100HT System X100HT with Full Field Peripheral Blood Smear (PBS) Application X100HT Digital Scanner X100HT Processing Unit K243144 (2025)
Athelas, Inc. United States Athelas Home Athelas One WBC Test Strip K243348 (2026)
Barco N.V. Present in Europe in other categories Belgium Barco K203364 (2021)
Biomedical Polymers, Inc. – BMP Medical Single Cytology Funnel w/ White Card Single Cytology Funnel w/ Brown Card Double Cytology Funnel w/ White Card and Caps BMP Medical Double Cytology Funnel w/ White Card (Bulk) BMP Medical Metal Cytology Clip registered
SABEU GmbH & Co. KG Germany cellQART® cytoQ® registered
Analytical Control Systems, Inc. United States Whole Blood Control Level I .02M Calcium Chloride Hemotec Whole Blood Control Kit Large Whole Blood Control Level III Whole Blood Control Level II K925340 (1993)
BIOSEAL United States Bioseal Inc. registered
Clarapath, Inc. United States ClaraBond™ Slide Coater Adhesive ClaraCut™ Blades ClaraTape™ Transfer Tape Clarapath™ SectionStar™ registered
Fisher Scientific Co., LLC United States Fisherbrand registered
Ventana Medical Systems, Inc. Present in Europe in other categories United States BenchMark GX BenchMark Special Stains Stainer Module BenchMark ULTRA PLUS Instrument VENTANA HE 600 System BenchMark ULTRA K242783 (2024)
ASP Health Inc. United States ASP POD ASP HOOD ASP VIAL ASP Device; ASP System; ROSE Prep pro registered
Bio/Data Corp. Present in Europe in other categories United States PAP-8E Software CD Tris Buffered Saline Lupus Anticoagulant Confirmation Reagent Sodium Citrate K893650 (1989)
CellaVision AB Present in Europe in other categories United States CellaVision® Body Fluid Application DM96 CellaVision® DM9600 CellaVision® DM1200 Automated Digital Morphology Analyzer DI-60 registered
Genea Biomedx Pty, Ltd. Australia Geri Connect Server (including software) Geri Embryo Incubator Geri Software Connect and Assess 2.0 Geri Software Connect and Assess 1.3 registered
Heine Optotechnik GmbH & Co. KG Present in Europe in other categories Germany FINOFF TRANSILLUMINATOR OPHTHALMIC EXAMINATION LAMP registered
Inova Diagnostics, Inc. Present in Europe in other categories United States NOVA Lite® DAPI ANA Kit NOVA View® AUTOLoader NOVA View® Automated Fluorescence Microscope NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit K153150 (2015)
Medical Packaging Corp. United States CytoSoft CYTO-PAK K870398 (1987)
Zumax Medical Co., LTD Present in Europe in other categories China zumax registered
AERO-MED, LLC – Aero-Med registered
Aggredyne, Inc. United States Aggreguide AggreDYNE AA Assay K181777 (2019)
BIO SB, INC. Present in Europe in other categories United States TintoStainer Plus Automated System Mini TintoStainer Plus Automated System TintoStainer Plus Automated System LX registered
Bernell – Bernell registered
DENTMATE TECHNOLOGY CO., LTD. Present in Europe in other categories Taiwan LUMINDEX registered
Kolplast C I Brazil KOLPLAST CELLPRESERV KOLPLAST K153128 (2017)
NORTH EOS INDUSTRIES INC. Present in Europe in other categories Taiwan EOS K963685 (1996)
Puritan Medical Products United States Puritan Histobrush® Puritan Histobrush Puritan Histobrush Cytology Brush K111681 (2012)
Streck Laboratories, Inc. Present in Europe in other categories United States ESR-Auto Plus ESR-10 Manual Rack registered
Team Technologies, Inc. United States Cytology Brush 6.5" Cytology Brush K971849 (1997)
Amico Diagnostic Incorporated Present in Europe in other categories United States Amico Diagnostic Illuminator registered
Applied Spectral Imaging , Ltd. Present in Europe in other categories Israel ASI IVD System K071398 (2007)
BIOCYTECH CORPORATION SDN. BHD. Present in Europe in other categories Malaysia PathTezt® registered
BIOMEDICAL DATA SOLUTIONS LIMITED Present in Europe in other categories United Kingdom ORTHO CONNECT registered
CUSTOM ASSEMBLIES, INC. United States Robbins Instruments registered
FUJIREBIO INC. Present in Europe in other categories – Beckman Coulter PK CMV-PA System Beckman Coulter PK TP System registered
Hua Yue Medical Technology Co., Ltd. China Harioculture TL-16 Time-lapse Incubator Time-lapse Incubator Capacity Expansion Module registered
LW SCIENTIFIC, INC. United States LW Scientific, Inc. registered
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. Present in Europe in other categories – QwikCheck Test Strips SQA-Vision Sperm Quality Analyzer registered
PRACTICON, INC. United States Lumindex 3 LED Transilluminator Standard 3mm Light Guide Lumindex 3 LED Transilluminator registered
RANFAC CORP. Present in Europe in other categories United States Ranfac Filter Assembly Cervos Filter Assembly registered
Sarstedt Aktiengesellschaft & Co.KG – Sediplus® S 200, 12 V DC Sediplus® S 2000 NX registered
Tecan U.S., Ltd. Present in Europe in other categories United States PROFI BLOT 48 PROFI BLOT T48 K933996 (1994)
VENOSCOPE, LLC United States Venoscope registered
VITRO SA Present in Europe in other categories Spain VitroStainer 42 NeoPATH Pro registered
Zeus Scientific, Inc. Present in Europe in other categories United States Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) registered
ANYBATTERY, INC United States Anybattery registered
Aesku.Diagnostics GmbH & Co. KG Present in Europe in other categories Germany HELIOS® Automated IFA System registered
Aesku.Systems GmbH & Co. KG Present in Europe in other categories – HELIOS registered
Airscan, Inc. United States ESR STAT 6 registered
BOUND TREE MEDICAL, LLC – Curaplex registered
Biobase Biodustry(Shandong)Co., Ltd. China BIOBASE registered
Biokit, S.A. Present in Europe in other categories Spain BIO-FLASH registered
Cole Instruments Inc United States Graft Processing Board registered
Cytogen, Inc. Present in Europe in other categories South Korea Smart Biopsy™ IF Stainer registered
DREW SCIENTIFIC, INC. United Kingdom JAS Diagnostics K071562 (2007)
FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA Brazil VF1000LED Vein locator registered
FABINJECT LLC United States VF1000LED Vein locator registered
FUJIFILM Healthcare Americas Corporation Present in Europe in other categories United States Synapse Pathology registered
HARDY DIAGNOSTICS United States QuickSlide™ registered
Hamamatsu Photonics K.K. Japan NanoZoomer S360MD Slide scanner system K260964 (2026)
Immudex ApS Denmark Dextramer CMV Kit K153538 (2017)
Innovative Med United States FatSilk registered
MARKETLAB INC. United States Marketlab, Inc registered
MDHC Life Technologies (Kunshan) Co., LTD. – MDHC registered
MICRO TYPING SYSTEMS, INC – MTS registered
NOVODIAX, INC. Present in Europe in other categories United States Q-STAIN® X Autostainer registered
Proscia, Inc. Present in Europe in other categories United States Concentriq AP-Dx K230839 (2024)
QIAGEN SCIENCES INC. Present in Europe in other categories United States digene® HC2 DNA Collection Device registered
RECE INTERNATIONAL CORPORATION – ViaMed registered
SKLAR CORPORATION – Sklar® registered
STERILE SAFEQUIP & CHEMICALS LLP – ZBT-ESR registered
Sigma-Aldrich, Inc. Present in Europe in other categories – MIDAS® III-Plus Automated Stainer registered
Stihler Electronic GmbH Present in Europe in other categories Germany ASTODIA registered
U.S. OPHTHALMIC, L.L.C. United States EZ-TRI-3600 registered
Vitrolife A/S Present in Europe in other categories Denmark EmbryoScope+ registered
ACTcellBIO CO., LTD. South Korea – registered
AD Supply Group Limited United Kingdom – registered
APRO SAFETY SUPPLIES INC. Taiwan – registered
Ad Astra Diagnostics, Inc. United States – K230878 (2023)
Addent, Inc. United States – registered
Advance Sentry Corporation United States – registered

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