Deltalab
Spain
44 others
A
IVDR, 98/79
Website
info@deltalabgroup.com
EUDAMED record
Report an error
Centre Europeen De Biotechnologie
France
30 others
A
IVDR, 98/79
contact@ceb-angers.fr
EUDAMED record
Report an error
Ustar Biotechnologies (Hangzhou)
EU representative : Lotus NL B.V. (Netherlands)
China
16 others
A
IVDR
Website
service@bioustar.com
EUDAMED record
Report an error
Gongdong FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
7 others
A
IVDR
EUDAMED record
Report an error
Hanhengmed FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
A-2.0, A-2.5, A-3.0, A-3.5, A-4.0, A-4.5, A-5.0, A-5.5, A-6.0 3 refs B-2.0, B-2.5, B-3.0, B-3.5, B-4.0, B-4.5, B-5.0, B-5.5, B-6.0 3 refs HPV-81-2, HPV-81-3, HPV-81-5, HPV-81-8, HPV-81-10, HPV-81-12 3 refs HPV-83-2, HPV-83-3, HPV-83-5, HPV-83-8, HPV-83-10, HPV-83-12 3 refs HPV-A-2, HPV-A-3, HPV-A-5, HPV-A-8, HPV-A-10, HPV-A-12 3 refs
6 others HPV-D-2, HPV-D-3, HPV-D-5, HPV-D-8, HPV-D-10, HPV-D-12 3 refs HPV-E-2, HPV-E-3, HPV-E-5, HPV-E-8, HPV-E-10, HPV-E-12 3 refs HPV-F-2, HPV-F-3, HPV-F-5, HPV-F-8, HPV-F-10, HPV-F-12 3 refs HPV-G-2, HPV-G-3, HPV-G-5, HPV-G-8, HPV-G-10, HPV-G-12 3 refs TCT-81-5, TCT-81-8, TCT-81-10, TCT-81-12, TCT-81-15, TCT-81-20 3 refs TCT-83-5, TCT-83-8, TCT-83-10, TCT-83-12, TCT-83-15, TCT-83-20 3 refs
A
IVDR
quality@hanhengmed.com
EUDAMED record
Report an error
Haimen Shengbang Laboratory Equipment FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
5 others
A
IVDR, 98/79
EUDAMED record
Report an error
Hbh Biotechnology FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
4 others
A
IVDR
EUDAMED record
Report an error
REAL Digital International FDA
EU representative : Casus Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
4 others
A
IVDR
EUDAMED record
Report an error
Vwr FDA
Belgium
4 others
–
98/79
Website
EUDAMED record
Report an error
Suzhou Shengtian Biotechnology
EU representative : Kingsmead Service B.V. (Netherlands)
China
3 others
A
IVDR
EUDAMED record
Report an error
Ayala Sample Kits
Spain
BLOOD SAMPLE COLLECTION KIT FOR THE HARMONY TEST CAL004.1, CAL011.01, CAL011.02, CAL011.03, CAL011.04, CAL011.05, CAL011.06, CAL011.07, CAL011.08, CAL011.081, CAL011.082, CAL011.083, CAL011.084, CAL011.085,ETC 3 refs KIT AIRTEST 210T SIBO LACTITOL 7ATFRU, 7ATLAC, 7ATSAC, 7SIBOGLU, 7SIBOLOL, 7ATSOR, 8ATFRU, 8ATLAC, 8ATSAC, 8SIBOGLU, 8SIBOLSA, 8SIBOLOL, 8ATGAL, 8ATSOR, 8ATXOL, S8ATFRU, S8SIBOGLU, S8ATXIL, ATFRU, ATFRSO, ATGAL, ATLAC, ATSAC, SIBOGLU, SIBOLOL, SIBOLSA, CAL016.1-3, CAL018.1-10, etc 3 refs KIT DE TOMA DE MUESTRA DE HECES PARA ESTUDIO FECAL MOLECULAR-C TMH, FECBQ, CLH, FECMICRO, FECMOL, FECMOL-1, HIIC, PHC, PHCI, CAL017.2, CAL017.3 3 refs KIT TOMA DE MUESTRA DE CABELLO PARA TEST DE MINERALES TÓXICOS CAL009 KIT TOMA DE MUESTRA DE ORINA PARA HISTAMINA EN ORINA CAL002, CAL005, CAL006.1 3 refs
2 others
A
IVDR
eudamed.ayalasamplekits@gmail.com
EUDAMED record
Report an error
Isomed
Spain
2 others
A
IVDR
Website
info@isomed.com
EUDAMED record
Report an error
Concepta Diagnostics
United Kingdom (ex Northern Ireland)
1 other
I
MDR
Website
info@conceptaivd.com
EUDAMED record
Report an error
Inuvi
EU representative : QbD RepS BV (Belgium)
United Kingdom (ex Northern Ireland)
1 other
A
IVDR
EUDAMED record
Report an error
Laborkrone
Germany
1 other
IIa
MDR
Website
EUDAMED record
Report an error
Anaclindiagnostics
Spain
Contenedor estéril 24 Horas Anaclin, embolsado individual, capacidad 1.800 mL (nominal 1.500 mL) Contenedor estéril 24 Horas para recogida de muestras, embolsado individual, capacidad 1.800 mL (nominal 1.500 mL) 98/79 Contenedor estéril 24 Horas para recogida de muestras capacidad 1.800 mL (nominal 1.500 mL) 98/79 Contenedor estéril para recogida de muestras (heces y esputos), capacidad 65 mL Contenedor estéril para recogida de heces, capacidad 65 mL (Ref. 112) 98/79 Contenedor estéril para recogida de muestras (orina, heces y esputo), capacidad 135 mL Contenedor estéril para recogida de muestras biológicas (orina, heces y esputo), capacidad 135 mL 98/79
–
98/79
EUDAMED record
Report an error
Gentrend
Czechia
A
IVDR
Website
EUDAMED record
Report an error
Mawidna FDA
EU representative : CEpartner4U (Netherlands)
United States
A
IVDR
Website
info@mawidna.com
EUDAMED record
Report an error
Aidshilfe
Germany
IIa
MDR
Website
EUDAMED record
Report an error
Bgi
Denmark
A
IVDR
Website
EUDAMED record
Report an error
Bioteke FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
ST6001 ST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-2 3 refs ST7001-3, ST8001-3, ST9001-3 3 refs
A
IVDR
Website
info@bioteke.cn
EUDAMED record
Report an error
Coyotebio
EU representative : QbD RepS BV (Belgium)
China
A
IVDR
sales@coyotebio.com
EUDAMED record
Report an error
Igenomix
Spain
A
IVDR
Website
Vigilance@vitrolife.com
EUDAMED record
Report an error
ITL Asia Pacific Sdn. Bhd
EU representative : Emergo Europe B.V. (Netherlands)
Malaysia
A
IVDR
Website
regulatory.affairs@itlbiomedical.com
EUDAMED record
Report an error
Kangjian FDA
EU representative : Zoustech S.L. (Spain)
China
A
IVDR, 98/79
EUDAMED record
Report an error
Lituo
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
Website
EUDAMED record
Report an error
MagBio Genomics FDA
EU representative : CEpartner4U (Netherlands)
United States
A
IVDR
Website
info@magbiogenomics.com
EUDAMED record
Report an error
Medesign
Germany
I
MDR
Website
info@medesign.de
EUDAMED record
Report an error
Remi Health
Germany
I, IIa
MDR
Website
EUDAMED record
Report an error
Sh24
EU representative : CS Life Sciences Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
EUDAMED record
Report an error
Suesse
Germany
A
IVDR
info@suesse.de
EUDAMED record
Report an error
VOC-Advanced Breath Diagnostics
Germany
I, A
IVDR, MDR
Website
info@voc-advancedbreathdiagnostics.de
EUDAMED record
Report an error
Zymo Research FDA
EU representative : BIOTIKA (France) and 1 other
United States
A
IVDR
info@zymoresearch.com
EUDAMED record
Report an error
Anhui Sinic Laboratory Medicine Technology
EU representative : MedPath GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Badiusen Biotechnology (Kunshan)
EU representative : Kingsmead Service B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Biobase FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
China
A
IVDR
EUDAMED record
Report an error
Biobase Diagnostic Technology (Shandong)
EU representative : Luxus Lebenswelt GmbH (Germany)
China
I, A
IVDR, MDR
EUDAMED record
Report an error
Bioer FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
Sample Preservative Fluid BSC82S1, BSC82M1, BSC82L1, BSC82N1, BSC82X1-A, BSC82X1-B, BSC82N1-1, BSC82X1-A1, BSC82X1-B1, BSC82X1-C1, BSC82X1-E1, BSC82N1-2, BSC82X1-A2, BSC82X1-B2, BSC82X1-C2, BSC82X1-E2 3 refs Universal Transport Medium BSC93X1-B3
A
IVDR
Website
ra_oversea@bioer.com.cn
EUDAMED record
Report an error
Cangzhou Shengfeng Plastic Product
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
CellPath FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
info@cellpath.com
EUDAMED record
Report an error
Cerascreen
Germany
A
IVDR
Website
EUDAMED record
Report an error
Greiner Bio-One
Austria
–
98/79
Website
regulatory-affairs.at@gbo.com
EUDAMED record
Report an error
Hybribio
EU representative : Kingsmead Service B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Ilabu
Poland
I
MDR
Website
EUDAMED record
Report an error
Jiangsu Xinkang Medical Instrument
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
A
IVDR
EUDAMED record
Report an error
Labmediaservis
Czechia
A
IVDR
Website
info@labmediaservis.cz
EUDAMED record
Report an error
Medico Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
info@medicoswab.com
EUDAMED record
Report an error
Ningbo HEALTH Gene Technologies
EU representative : Lotus NL B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
QuinTron Instrument FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
A
IVDR
Website
regulatory@quintron-usa.com
EUDAMED record
Report an error
Specchiasol
Italy
IIa
MDR
EUDAMED record
Report an error
Utsat
Türkiye
A
IVDR
Website
info@utsat.com.tr
EUDAMED record
Report an error
Vitro FDA
Spain
A
IVDR
Website
regulatory@vitro.bio
EUDAMED record
Report an error
Biosynex
France
A
IVDR
Website
reglementaire@biosynex.com
EUDAMED record
Report an error
Qiagen FDA
EU representative : QIAGEN GmbH (Germany)
Germany, United States
I
MDR
Website
info@qiagen.com
EUDAMED record
Report an error
2cureX
Denmark
A
IVDR
Website
support@2curex.com
EUDAMED record
Report an error
Abbott FDA
EU representative : Abbott GmbH (Germany)
United States
A
IVDR
EUDAMED record
Report an error
Acro Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany)
United States
A
IVDR
info@acrobiotech.com
EUDAMED record
Report an error
Acumenbio
EU representative : Kingsmead Service B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Advanced Breath Diagnostics Dbacairn Diagnostics
EU representative : Emergo Europe B.V. (Netherlands)
United States
A
IVDR
EUDAMED record
Report an error
Autobio FDA
EU representative : Obelis s.a. (Belgium)
China
A
IVDR
Website
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
Beaverbio
EU representative : Kingsmead Service B.V. (Netherlands)
China
A
IVDR
sales@beaverbio.com
EUDAMED record
Report an error
Beijing Applied Biological Technologies
EU representative : Luxus Lebenswelt GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Bio-Optica Milano FDA
Italy
A
IVDR
Website
info@bio-optica.it
EUDAMED record
Report an error
Biocytech Sdn Bhd FDA
EU representative : SUNGO Europe B.V. (Netherlands)
Malaysia
I
MDR
EUDAMED record
Report an error
Bioperfectus FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Cangzhou Fukang Medical Supplies
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Centogene
Germany
A
IVDR
Website
regulatory.affairs@centogene.com
EUDAMED record
Report an error
Cesna
Türkiye
A
IVDR
Website
info@cesna.com.tr
EUDAMED record
Report an error
Chengwumedical
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Cowingene
EU representative : MedPath GmbH (Germany)
China
A
IVDR
Website
EUDAMED record
Report an error
DasLab
Germany
I
MDR
Website
contact@daslab.health
EUDAMED record
Report an error
Ddk Italia
Italy
A
IVDR
info@ddkitalia.com
EUDAMED record
Report an error
Diagante
France
A
IVDR
contact@diagante.com
EUDAMED record
Report an error
Dignity Care Network FDA
EU representative : IMed EUAR Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
Contact@DignityCareNetwork.com
EUDAMED record
Report an error
ETest Medical Electronic Technology(NanTong)
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Eurobio Scientific
France
A
IVDR
reglementaire@eurobio-scientific.com
EUDAMED record
Report an error
Fischer ANalysen Instrumente FDA
Germany
A
IVDR
Website
EUDAMED record
Report an error
Geneally
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
info@geneally.com.cn
EUDAMED record
Report an error
Genedrive
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
EUDAMED record
Report an error
Genfine
EU representative : MedPath GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Gp Medical Devices A S FDA
Denmark
A
IVDR
Website
EUDAMED record
Report an error
Guangxihuadu
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
Sales@guangxihuadu.com
EUDAMED record
Report an error
Guangzhou Richen-Frinse Optical &Electronic
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
EUDAMED record
Report an error
Hain Lifescience
Germany
IIa
MDR
EUDAMED record
Report an error
Hangzhou Danwei Biotechnology FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
–
98/79
ra.danwei@danwei-bio.com
EUDAMED record
Report an error
Hangzhou Genesis Biodetection Biocontrol FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
Website
EUDAMED record
Report an error
Hangzhou New Horizon Health Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
A
IVDR
Website
compliance@nhbio.com.cn
EUDAMED record
Report an error
Healgen FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
United States
–
98/79
EUDAMED record
Report an error
Hertility Health
EU representative : QbD RepS BV (Belgium)
United Kingdom (ex Northern Ireland)
A
IVDR
EUDAMED record
Report an error
Huachenyang (Shenzhen) Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
Sample Collection Kit CY-90001T,CY-93050T,CY-93050TS,CY-93050RT,CY-96000T,CY-98000TS,CY-F1-10,CY-90003T-Stuart,CY-90003T-Amies,CY-90003T-Cary Blair,CY-F005-10,CY-93050AM,CY-90002T,CY-95000BM,CY98000T, etc 3 refs
A
IVDR
EUDAMED record
Report an error
Immunodiagnostic Systems FDA
EU representative : Immunodiagnostic Systems SA (Belgium)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
EUDAMED record
Report an error
Ims Giotto FDA
Italy
A
IVDR
Website
EUDAMED record
Report an error
Innovative Biotechnology Organization Trade
Türkiye
A
IVDR
Website
info@tibobio.org
EUDAMED record
Report an error
Jiangsu Comeon Medical Apparatus
EU representative : Sungo Cert GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
marketing@hongweitest.com
EUDAMED record
Report an error
Jinquanmedical
EU representative : SUNGO Europe B.V. (Netherlands)
China
Tissue Embedding Cassette JQEB-001, JQEB-002, JQEB-003, JQEB-004, JQEB-005, JQEB-006, JQEB-007, JQEB-008, JQEB-009, JQEB-010, JQEB-011, JQEB-012, JQEB-013, JQEB-014, JQEB-015, JQEB-016, JQEB-017, JQEB-018, JQEB-019, JQEB-020, JQEB-021, etc 3 refs
A
IVDR
sales1@jinquanmedical.com
EUDAMED record
Report an error
Junogenetics
Spain
A
IVDR
Website
supportspain@junogenetics.com
EUDAMED record
Report an error
Konsung FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
EUDAMED record
Report an error
Labonovum
Netherlands
A
IVDR
Website
info@labonovum.com
EUDAMED record
Report an error
Lind Membrane(Xiamen) Healthcare
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Medfor
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
quality@medfor.co.uk
EUDAMED record
Report an error
Medikal Olusum Sanayi Ve Ticaret Sirketi
Türkiye
A
IVDR
Website
info@moslab.com
EUDAMED record
Report an error
Miraclean Technology FDA
EU representative : Share info GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
MolGen
Netherlands
A
IVDR
Website
info@molgen.com
EUDAMED record
Report an error
Nanchang Chaoyang Medical Health Products
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Nanjing Norman Biological Technology
EU representative : Sungo Cert GmbH (Germany)
China
240μL/tube,300μL/tube,400μL/tube,500μL/tube,600μL/tube,800μL/tube,1mL/tube,1.5mL/tube,2.0mL/tube,2.5mL/tube,3.0mL/tube,3.5mL/tube,5mL/tube,6mL/tube 3 refs
A
IVDR
EUDAMED record
Report an error
Natera FDA
EU representative : QbD RepS BV (Belgium)
United States
A
IVDR
Website
support@natera.com
EUDAMED record
Report an error
Norgen Biotek
EU representative : Emergo Europe B.V. (Netherlands)
Canada
–
98/79
Website
regulatory@norgenbiotek.com
EUDAMED record
Report an error
Orientgene FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
–
98/79
EUDAMED record
Report an error
Prenetics
EU representative : Obelis s.a. (Belgium)
Hong Kong SAR China
A
IVDR
EUDAMED record
Report an error
PrivaPath Diagnostics FDA
Ireland
A
IVDR
Website
support@letsgetchecked.com
EUDAMED record
Report an error
RM Life Science
EU representative : Javitech Consulting GmbH (Germany)
South Korea
A
IVDR
EUDAMED record
Report an error
Sanmen Minsheng Medical Appliances
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
SBT Sağlık Bilim ve Teknolojileri A.Ş
Türkiye
A
IVDR
Website
info@sbtas.com.tr
EUDAMED record
Report an error
Seekya
EU representative : Share info GmbH (Germany)
China
B
IVDR
EUDAMED record
Report an error
Seindabio
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Serosep FDA
Ireland
A
IVDR
Website
info@serosep.com
EUDAMED record
Report an error
Shandong Bohong Gene Technology
EU representative : Luxus Lebenswelt GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Shanghai Chuangkun Biotech
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Shenzhen Freecom Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Singuway
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
sales@singuway.com
EUDAMED record
Report an error
Sinopharm
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Transgen
EU representative : Kingsmead Service B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Triplex International Biosciences (China)
EU representative : Lotus NL B.V. (Netherlands)
China
–
98/79
Website
info@tibchina.com
EUDAMED record
Report an error
vivatura
Germany
IIa
MDR
Website
EUDAMED record
Report an error
Wuxi NEST Biotechnology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Xambika
Netherlands
A
IVDR
Website
eudamed@iq-womenshealth.com
EUDAMED record
Report an error
Xi An Tianlong Science Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Xiaogan Kuohai Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Youpubiotech
EU representative : MedPath GmbH (Germany)
China
A
IVDR
ra@youpubiotech.com
EUDAMED record
Report an error
Zhejiang Aicor Medical Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Biomes
No model still on the market
Germany
A
IVDR
Website
info@biomes.world
EUDAMED record
Report an error
Mobidiag
No model still on the market
Finland
A
IVDR
Website
sales.mob@hologic.com
EUDAMED record
Report an error