| Sentinel FDA
|
Italy
|
7 others
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Pharmasave
|
Romania
|
4 others
|
A
IVDR, 98/79
|
OFFICE@PHARMASAVE.RO
EUDAMED record
Report an error
|
| Sarstedt FDA
|
Germany
|
3 others
|
A
IVDR, 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
|
| Meridian Bioscience FDA
EU representative : Meridian Bioscience Europe S.r.l. (Italy)
|
United States
|
2 others
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Centre Europeen De Biotechnologie
|
France
|
1 other
|
A
IVDR, 98/79
|
contact@ceb-angers.fr
EUDAMED record
Report an error
|
| Keyubio
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
1 other
|
A
IVDR
|
Website
export@keyubio.com
EUDAMED record
Report an error
|
| Norgen Biotek
EU representative : Emergo Europe B.V. (Netherlands)
|
Canada
|
1 other
|
A
IVDR
|
Website
regulatory@norgenbiotek.com
EUDAMED record
Report an error
|
| Weihai Sunway Medical Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
1 other
|
A
IVDR
|
EUDAMED record
Report an error
|
| ALS Life Sciences Portugal
|
Portugal
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Immundiagnostik FDA
|
Germany
|
|
A
IVDR
|
Website
info@immundiagnostik.com
EUDAMED record
Report an error
|
| Linear FDA
|
Spain
|
|
A
IVDR
|
Website
info@linear.es
EUDAMED record
Report an error
|
| Schebo FDA
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Suntrine
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
A
IVDR
|
service@suntrine.com
EUDAMED record
Report an error
|
| Anicrin
|
Italy
|
|
A
IVDR, 98/79
|
Website
info@anicrin.com
EUDAMED record
Report an error
|
| DNA Genotek FDA
EU representative : QbD RepS BV (Belgium)
|
Canada
|
|
A
IVDR
|
Website
regulatory@dnagenotek.com
EUDAMED record
Report an error
|
| Gp Medical Devices A S FDA
|
Denmark
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Medical Wire & Equipment Bath
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
Website
info@mwe.co.uk
EUDAMED record
Report an error
|
| Randox FDA
|
Northern Ireland
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Zymo Research FDA
EU representative : DAVID Catherine Elisabeth Marie (France)
|
United States
|
|
A
IVDR
|
info@zymoresearch.com
EUDAMED record
Report an error
|
| Amsino FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
I
93/42
|
EUDAMED record
Report an error
|
| Aptaca FDA
|
Italy
|
|
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
|
| Bgi
|
Denmark
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Biohit FDA
|
Finland
|
|
A
IVDR
|
Website
info@biohit.fi
EUDAMED record
Report an error
|
| Biosynex
|
France
|
|
A
IVDR
|
Website
reglementaire@biosynex.com
EUDAMED record
Report an error
|
| Biosystems FDA
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Cell Projects FDA
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Cerascreen
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Chengwumedical
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Codisan
|
Italy
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Durviz
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Eiken FDA
EU representative : Advena Limited (Malta)
|
Japan
|
|
A
IVDR
|
regulatoryaffairs@eiken.co.jp
EUDAMED record
Report an error
|
| El-Comp Cezary Kostuch
|
Poland
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| for you eHealth
|
Germany
|
|
I
MDR
|
Website
info@foryouehealth.de
EUDAMED record
Report an error
|
| Gcmedica
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
IIa
93/42
|
EUDAMED record
Report an error
|
| Haimen Shengbang Laboratory Equipment FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Hanhengmed FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
quality@hanhengmed.com
EUDAMED record
Report an error
|
| Hubei V-Medical Products FDA
EU representative : RAFFIN MEDICAL (France)
|
China
|
|
I
MDR
|
Website
quality-liutao@v-medicalchina.com
EUDAMED record
Report an error
|
| Jiangsu CoWin Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Kangjian FDA
EU representative : Zoustech S.L. (Spain)
|
China
|
|
A
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Mascia Brunelli
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Meddo
|
Romania
|
|
A
IVDR
|
Website
office@meddo.ro
EUDAMED record
Report an error
|
| Microtrace
|
Italy
|
|
A
IVDR
|
Website
office@microtrace.it
EUDAMED record
Report an error
|
| Miraclean Technology FDA
EU representative : Share info GmbH (Germany)
|
China
|
- Disposable stool sample collection kit FB-YT01
- Saliva Collection Kit TY180, TY180F, TY180D, TY001A, TY001AF, TY001D, TY001B, TY002A-10.0, TY002AF-10.0, TY002AD-10.0, TY002B-10.0, TY003A-5.0, TY003AF-5.0, TY003AD-5.0,TY003B-5.0, TY004A-6.0, TY004AF-6.0, TY004AD-6.0,TY004B-6.03 refs
|
A
IVDR
|
EUDAMED record
Report an error
|
| Specchiasol
|
Italy
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Spinreact
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Vecmedical FDA
|
Spain
|
|
–
98/79
|
Website
eudamed@vecmedical.com
EUDAMED record
Report an error
|
| Wuhan MGI Tech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Xiamen Sciendox Biological Technology
EU representative : MedPath GmbH (Germany)
|
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
|
| Abbexa
EU representative : Abbexa BV (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
Website
info@abbexa.com
EUDAMED record
Report an error
|
| Aidian FDA
|
Finland
|
|
A
IVDR
|
Website
eudamed@aidian.eu
EUDAMED record
Report an error
|
| Alfresa Pharma FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
Japan
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Aquisel FDA
|
Spain
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Assure Tech. (Hangzhou)
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
Website
contact@diareagent.com
EUDAMED record
Report an error
|
| Beaverbio
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
A
IVDR
|
sales@beaverbio.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
|
| Benoylab
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Sale02@benoylab.com
EUDAMED record
Report an error
|
| Bio-Optica Milano FDA
|
Italy
|
|
A
IVDR
|
Website
info@bio-optica.it
EUDAMED record
Report an error
|
| Biolifeit
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Biome Diagnostics
|
Austria
|
|
A
IVDR
|
Website
service@biome-dx.com
EUDAMED record
Report an error
|
| Biomes
|
Germany
|
|
A
IVDR
|
Website
info@biomes.world
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
|
| Boettger
|
Germany
|
|
A
IVDR
|
Website
sales@boettger.com
EUDAMED record
Report an error
|
| Calibrescientific FDA
EU representative : MDSS GmbH (Germany)
|
United States
|
|
A
IVDR
|
Website
regulatory@calibrescientific.com
EUDAMED record
Report an error
|
| Calpro
|
Norway
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Cavanbio
EU representative : HyperCert Limited B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Certest
|
Spain
|
|
A
IVDR
|
Website
quality@certest.es
EUDAMED record
Report an error
|
| Citotest FDA
EU representative : Obelis s.a. (Belgium)
|
China
|
|
A
IVDR
|
Website
info@citotest.com
EUDAMED record
Report an error
|
| Comedical
|
Italy
|
|
A
IVDR
|
Website
info@comedical.biz
EUDAMED record
Report an error
|
| Creativebio
EU representative : Obelis s.a. (Belgium)
|
China
|
|
A
IVDR
|
Website
Service@creativebio.cn
EUDAMED record
Report an error
|
| DasLab
|
Germany
|
|
I
MDR
|
Website
contact@daslab.health
EUDAMED record
Report an error
|
| Dianext
|
Italy
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Diazyme FDA
EU representative : MDSS GmbH (Germany)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Dnameter
|
Czechia
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Doctorbox
|
Germany
|
|
I
MDR
|
Website
info@doctorbox.de
EUDAMED record
Report an error
|
| Dragon Medical FDA
EU representative : MedPath GmbH (Germany)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| DRG Instruments
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Eurobio Scientific
|
France
|
|
A
IVDR
|
reglementaire@eurobio-scientific.com
EUDAMED record
Report an error
|
| Eurolyser
|
Austria
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Eurospital FDA
|
Italy
|
|
A
IVDR
|
regulatory@eurospital.it
EUDAMED record
Report an error
|
| FertiPro FDA
|
Belgium
|
|
A
IVDR
|
Website
info@fertipro.com
EUDAMED record
Report an error
|
| Gaudlitz
|
Germany
|
|
A
IVDR
|
Website
info@gaudlitz.de
EUDAMED record
Report an error
|
| Genebiohealth
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
marketing@genebiohealth.com
EUDAMED record
Report an error
|
| Geneproof
|
Czechia
|
|
A
IVDR
|
Website
support@geneproof.com
EUDAMED record
Report an error
|
| Genomictree
EU representative : KTR Europe GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Gongdong FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Goodgut
|
Spain
|
|
A
IVDR
|
Website
info@goodgut.eu
EUDAMED record
Report an error
|
| Handan FCH Medical Technology
EU representative : MedPath GmbH (Germany)
|
China
|
|
I
MDR
|
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
|
| Happy Innova
|
Spain
|
|
A
IVDR
|
Website
hello@thesmartlollipop.com
EUDAMED record
Report an error
|
| I.S.E. - Societa' A Responsabilita' Limitata - Sistemi Intelligenti Elettronici
|
Italy
|
|
A
IVDR
|
Website
info@logotech-ise.com
EUDAMED record
Report an error
|
| IBL International
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Ilabu
|
Poland
|
|
I
MDR
|
Website
EUDAMED record
Report an error
|
| Inova Diagnostics FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Jiangsu Comeon Medical Apparatus
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
A
IVDR
|
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 Mole Bioscience
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Kaltek
|
Italy
|
|
A
IVDR
|
info@kaltek.it
EUDAMED record
Report an error
|
| Laborkrone
|
Germany
|
|
I
MDR
|
Website
EUDAMED record
Report an error
|
| Lituo
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Mavie
|
Austria
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Medical FDA
EU representative : Obelis s.a. (Belgium)
|
Japan
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Medichecks
EU representative : CS Life Sciences Europe Ltd (Ireland)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
Website
qualityandregs@medichecks.com
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
|
| Medikal Olusum Sanayi Ve Ticaret Sirketi
|
Türkiye
|
|
A
IVDR
|
Website
info@moslab.com
EUDAMED record
Report an error
|
| Meus FDA
|
Italy
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Microgenics FDA
EU representative : B·R·A·H·M·S GmbH (Germany)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Microviable
|
Spain
|
|
A
IVDR
|
Website
admin@microviable.com
EUDAMED record
Report an error
|
| Mirnax Biosens
|
Spain
|
|
A
IVDR
|
info@mirnaxbiosens.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
|
| Novogenia FDA
|
Austria
|
|
A
IVDR
|
Website
service@novogenia.com
EUDAMED record
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|
| Oacp
|
Ireland
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Olgunmedikal
|
Türkiye
|
|
A
IVDR
|
info@olgunmedikal.com
EUDAMED record
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|
| Orgentec
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
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|
| PrivaPath Diagnostics FDA
|
Ireland
|
|
A
IVDR
|
Website
support@letsgetchecked.com
EUDAMED record
Report an error
|
| ProciseDx FDA
EU representative : QbD RepS BV (Belgium)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| REAL Digital International FDA
EU representative : Casus Europe B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Remi Health
|
Germany
|
|
I
MDR
|
Website
EUDAMED record
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|
| Sc Spd Star
|
Romania
|
|
A
IVDR
|
Website
OFFICE@SPDGROUP.RO
EUDAMED record
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|
| Shandong Chengwu Ronghua Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Sichuan Orienter Biotechnology
EU representative : Share info GmbH (Germany)
|
China
|
|
A
IVDR
|
Website
info@orienterglobal.com
EUDAMED record
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|
| Sinopharm
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Taizhou Huangyan Fangye Technology Development
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Taizhou Kangwei Medical Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Teletest
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
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|
| TimeTeller
|
Germany
|
|
A
IVDR
|
EUDAMED record
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|
| vivatura
|
Germany
|
|
I
MDR
|
Website
EUDAMED record
Report an error
|
| Wuhan Ammunition Life-tech
EU representative : Medunion S.L. (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Xiamen Zeesan Biotech FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
info@zsandx.com
EUDAMED record
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|
| Yanengbio
EU representative : Obelis s.a. (Belgium)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Zhucheng Binfei Medi-Tek
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
I
MDR
|
admin@binfei-medtek.com
EUDAMED record
Report an error
|
| Lykon
No model still on the market
|
Germany
|
|
I
MDR
|
quality@lykon.com
EUDAMED record
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