| Atlas Medical FDA
|
Germany
|
- Atlas Salmonella Antigen , Widal (6 Antigens: OA, OB, OD, HA, HB, HD) 8.01.18.0.003098/79
- Atlas Salmonella Antigen Set: 8 Antigens ( OA,OB,OC,OD, HA,HB,HC,HD), With controls. 8.01.16.1.004098/79
- Atlas Salmonella Antigen Set: 8 Antigens ( OA,OB,OC,OD, HA,HB,HC,HD). 8.01.16.0.004098/79
- Atlas Salmonella HA Reagent , 5 ml/vial, 8 vials/Box. 8.01.05.1.004098/79
- Atlas Salmonella HA Reagent, 5 ml/vial, 1 vial/Box. 8.01.05.0.000598/79
14 others- Atlas Salmonella HB Reagent, 5 ml/vial, 1 vial/Box. 8.01.06.0.000598/79
- Atlas Salmonella HB Reagent, 5 ml/vial, 8 vials/Box. 8.01.06.1.004098/79
- Atlas Salmonella HC Reagent, 5 ml/vial, 1 vial/Box. 8.01.07.0.000598/79
- Atlas Salmonella HC Reagent, 5 ml/vial, 8 vials/Box. 8.01.07.1.004098/79
- Atlas Salmonella HD Reagent, 5 ml/vial, 1 vial/Box. 8.01.08.0.000598/79
- Atlas Salmonella HD Reagent, 5 ml/vial, 8 vials/Box. 8.01.08.1.004098/79
- Atlas Salmonella OA Reagent , 5 ml/vial, 1 vial/Box. 8.01.01.0.000598/79
- Atlas Salmonella OA Reagent , 5 ml/vial, 8 vials/Box. 8.01.01.1.004098/79
- Atlas Salmonella OB Reagent , 5 ml/vial, 8 vials/Box. 8.01.02.1.004098/79
- Atlas Salmonella OB Reagent, 5 ml/vial, 1 vial/Box. 8.01.02.0.000598/79
- Atlas Salmonella OC Reagent , 5 ml/vial, 8 vials/Box. 8.01.03.1.004098/79
- Atlas Salmonella OC Reagent, 5 ml/vial, 1 vial/Box. 8.01.03.0.000598/79
- Atlas Salmonella OD Reagent , 5 ml/vial, 8 vials/Box. 8.01.04.1.004098/79
- Atlas Salmonella OD Reagent, 5 ml/vial, 1 vial/Box. 8.01.04.0.000598/79
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–
98/79
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Website
info@atlas-medical.com
EUDAMED record
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| Fortress Diagnostics
|
Northern Ireland
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14 others
|
–
98/79
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Website
info@fortressdiagnostics.com
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| Chronolab
|
Spain
|
11 others- Salmonella Paratyphi BH, 20 x 5 mL98/79
- Salmonella Paratyphi BO, 1 x 5 mL98/79
- Salmonella Paratyphi BO, 20 x 5 mL98/79
- Salmonella Paratyphi CH, 1 x 5 mL98/79
- Salmonella Paratyphi CH, 20 x 5 mL98/79
- Salmonella Paratyphi CO, 1 x 5 mL98/79
- Salmonella Paratyphi CO, 20 x 5 mL98/79
- Salmonella Typhi H, 1 x 5 mL98/79
- Salmonella Typhi H, 20 x 5 mL98/79
- Salmonella Typhi O, 1 x 5 mL98/79
- Salmonella Typhi O, 20 x 5 mL98/79
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98/79
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Website
info@chronolab.com
EUDAMED record
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| Egyptian For Biotechnology-Spectrum Diagnostics
EU representative : MDSS GmbH (Germany)
|
Egypt
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11 others
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–
98/79
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Website
info@spectrum-diagnostics.com
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| Hangzhou Alltest Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
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10 others
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98/79
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info@alltests.com.cn
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| Sanymed
|
Italy
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7 others
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–
98/79
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Website
info@sanymed.it
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| Vitrosens
|
Türkiye
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7 others
|
C
IVDR, 98/79
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Website
info@vitrosens.com
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| LTA
|
Italy
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6 others
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–
98/79
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Website
office@ltaonline.it
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| Diagnostics
|
Belgium
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4 others
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–
98/79
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Website
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| Dialab
|
Austria
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4 others
|
–
98/79
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Website
office@dialab.at
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| Rapid Labs
EU representative : Advena Limited (Malta)
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United Kingdom (ex Northern Ireland)
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4 others
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–
98/79
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Website
info@rapidlabs.co.uk
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| Giesse Diagnostics
|
Italy
|
3 others
|
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98/79
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Website
info@giessediagnostics.com
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| Lorne Laboratories
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
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3 others
|
–
98/79
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Website
info@lornelabs.com
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| Acro Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
United States
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2 others
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–
98/79
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info@acrobiotech.com
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| Kangsheng Information Technology (Hangzhou)
EU representative : Crealkraft GmbH (Germany)
|
China
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1 other
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–
98/79
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EUDAMED record
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| BeijingModern GaoDa Biotechnology
EU representative : Medunion S.L. (Spain)
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China
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|
–
98/79
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EUDAMED record
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| Spectrum For Diagnostic Industries Joint Stock
EU representative : MDSS GmbH (Germany)
|
Egypt
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|
–
98/79
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Website
EUDAMED record
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| Abbott FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
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South Korea
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–
98/79
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Website
EUDAMED record
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| Healgen FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
United States
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|
–
98/79
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quality@healgen.com
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| Nexlab
EU representative : MedNet EC-REP GmbH (Germany)
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China
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–
98/79
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EUDAMED record
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| Orientgene FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
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China
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|
–
98/79
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EUDAMED record
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| Sansure FDA
EU representative : Obelis s.a. (Belgium)
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China
|
|
–
98/79
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Website
info@sansure.com.cn
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| Shanghai Zj Bio-Tech FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
Website
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|
| Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇
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Türkiye
|
|
C
IVDR
|
Website
info@visionbiotechnology.com
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| Assure Tech. (Hangzhou)
EU representative : Lotus NL B.V. (Netherlands)
|
China
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|
–
98/79
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Website
contact@diareagent.com
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| Beijing Applied Biological Technologies
EU representative : Luxus Lebenswelt GmbH (Germany)
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China
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|
–
98/79
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EUDAMED record
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| Beijing Jinwofu Bioengineering Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
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China
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–
98/79
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EUDAMED record
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| Cybereagen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
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info@cybereagen.com
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| Encode
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
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|
–
98/79
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Website
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| Genesignbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
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info@genesignbio.com
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| HangZhou Biotest Biotech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
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info@biotests.com.cn
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| Human
|
Germany
|
|
–
98/79
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Website
EUDAMED record
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| Kalians
EU representative : MDSS GmbH (Germany)
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Egypt
|
|
–
98/79
|
EUDAMED record
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| Lysunbio FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
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EUDAMED record
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| Realytech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
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Website
info@realytech.com
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| Suzhou TianLong Biotechnology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
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EUDAMED record
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| Zhejiang Greylynx Biotech
EU representative : Lotus NL B.V. (Netherlands)
|
China
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|
–
98/79
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info@vivachek.com
EUDAMED record
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| Zhejiang QL Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
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| Aconbio
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
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Website
EUDAMED record
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|
| Anhui Deepblue Medical Technology FDA
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
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sales@dbluemedical.com
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| Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi
|
Türkiye
|
|
–
98/79
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Website
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|
| Dezhou Guoke Medical Technology
EU representative : MedPath GmbH (Germany)
|
China
|
|
–
98/79
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office@guoke-medical.com
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| Diagreat
EU representative : Medunion S.L. (Spain)
|
China
|
|
C
IVDR
|
Website
info@diagreat.com
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|
| Hangzhou Immuno Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
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info@jgbiotech.com
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| Idilbiotech
|
Türkiye
|
|
–
98/79
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Website
EUDAMED record
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| KH Medical
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
–
98/79
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Website
info@khmedical.co.kr
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|
| Kogene
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
|
–
98/79
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Website
info@kogene.co.kr
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| Limingbio
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
–
98/79
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Website
sales@limingbio.com
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| Mpbio FDA
|
Germany
|
|
–
98/79
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Website
EUDAMED record
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| Nanjing Synthgene Medical Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
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Website
sales@syngenebio.com
EUDAMED record
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| Oxoid FDA
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
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B
IVDR
|
Website
EUDAMED record
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| Poly Diagnostics
|
Luxembourg
|
|
B
IVDR
|
Website
info@polydiagnostics.com
EUDAMED record
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| Sejoy FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
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Website
EUDAMED record
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| Shenzhen Zijian Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
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Website
sales@szzijian.com
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| Spinreact
|
Spain
|
|
–
98/79
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Website
EUDAMED record
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| SSI Diagnostica FDA
|
Denmark
|
|
–
98/79
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Website
info@ssidiagnostica.com
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| TIB MOLBIOL Syntheselabor
|
Germany
|
|
–
98/79
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Website
EUDAMED record
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| Vela Operations Singapore Pte FDA
EU representative : Vela Diagnostics Germany GmbH (Germany)
|
Singapore
|
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–
98/79
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Website
infoAPAC@veladx.com
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| Viuick
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
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EUDAMED record
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| Wondfo FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
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Website
sales@wondfo.com.cn
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| Vitro Scient
EU representative : MDSS GmbH (Germany)
No model still on the market
|
Egypt
|
7 others
|
–
98/79
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Website
info@vitroscient.com
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| IDL Biotech
No model still on the market
|
Sweden
|
|
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98/79
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Website
EUDAMED record
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| Zhejiang Anji Saianfu Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
No model still on the market
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China
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|
–
98/79
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EUDAMED record
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| Chemelex
No model still on the market
|
Spain
|
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–
98/79
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Website
EUDAMED record
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| Nantong EgensBiotechnology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
No model still on the market
|
China
|
|
–
98/79
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qa@egens-bio.cn
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