IVD instrumentsHematology / histology / cytology instrumentsHaematology / cell counting
Limited panel cell counting analysers
EMDN code W02020102
Manufacturers registered in Europe (EUDAMED) 39
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Dymind EU representative : Eunitor GmbH (Germany) | China | A, B IVDR, 98/79 | regulationdept@dymind.com EUDAMED record Report an error | |
| Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
7 others
|
B IVDR, 98/79 | Website support@rayto.com EUDAMED record Report an error |
| E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | – 98/79 | EUDAMED record Report an error | |
| Wheisman Medical Technology EU representative : Umedwings Netherlands B.V. (Netherlands) | China |
1 other |
– 98/79 | EUDAMED record Report an error |
| Diatron FDA | Hungary | A IVDR | Website EUDAMED record Report an error | |
| Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) | China | B IVDR, 98/79 | Website service@genrui-bio.com 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 | |
| Sysmex FDA EU representative : Sysmex Europe SE (Germany) | Japan | – 98/79 | ra_archive@sysmex.co.jp EUDAMED record Report an error | |
| Accriva Diagnostics FDA EU representative : MDSS GmbH (Germany) | United States | A IVDR | Website EUDAMED record Report an error | |
| Boule FDA | Sweden |
|
B IVDR | Website info@boule.com 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 | |
| Gmt Sarl | France | – 98/79 | Website EUDAMED record Report an error | |
| Human | Germany |
|
– 98/79 | Website EUDAMED record Report an error |
| Hunan Ehome Health Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other | China | A IVDR | info@infitek.com EUDAMED record Report an error | |
| Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
– 98/79 | EUDAMED record Report an error |
| NORMA Instruments Zártkörűen Működő Részvénytársaság | Hungary | A IVDR | 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 | |
| Spinreact | Spain |
|
– 98/79 | Website EUDAMED record Report an error |
| Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | B IVDR, 98/79 | Website service@uritest.com EUDAMED record Report an error | |
| Zybio FDA EU representative : QbD RepS BV (Belgium) | China | B IVDR | PMS@zy-ivd.com EUDAMED record Report an error | |
| Abbott FDA EU representative : Abbott GmbH (Germany) | United States | B IVDR | Website EUDAMED record Report an error | |
| Aconbio EU representative : MedNet EC-REP GmbH (Germany) | China |
|
– 98/79 | Website EUDAMED record Report an error |
| Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) | China | A IVDR | 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 | |
| Diagnostics | Belgium |
|
– 98/79 | Website EUDAMED record Report an error |
| Diagon | Hungary | A IVDR | Website EUDAMED record Report an error | |
| Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | B IVDR | EUDAMED record Report an error | |
| EKF-diagnostic FDA | Germany |
|
B IVDR | info@ekf-diagnostic.de EUDAMED record Report an error |
| Erba | Czechia | B IVDR | Website EUDAMED record Report an error | |
| High Technology FDA EU representative : MedEnvoy Global BV (Netherlands) | United States | A IVDR | Website EUDAMED record Report an error | |
| Horiba FDA | France |
|
– 98/79 | 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 | |
| Lordsmark EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website EUDAMED record Report an error | |
| Ningbo MedicalSystem Biotechnology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | EUDAMED record Report an error | |
| ZOVEC diagnostics | Germany |
|
– 98/79 | 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 |
| Xpenarray EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market | China |
|
– 98/79 | 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.
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