IVD instrumentsChemistry / immunochemistry instrumentsElectrophoresis / chromatography instruments
Chromatography instruments (hplc)
EMDN code W02010502
Manufacturers registered in Europe (EUDAMED) 14
- 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 |
|---|---|---|---|---|
| Immundiagnostik FDA | Germany |
7 others |
– 98/79 | Website info@immundiagnostik.com EUDAMED record Report an error |
| Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other | China | A IVDR, 98/79 | Website EUDAMED record Report an error | |
| Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) | Japan |
1 other |
A IVDR, 98/79 | support_arkrayeurope@arkray.co.jp EUDAMED record Report an error |
| Shimadzu FDA EU representative : Shimadzu Europa GmbH (Germany) | Japan | A IVDR, 98/79 | Website EUDAMED record Report an error | |
| Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | – 98/79 | sales@ukinbio.com EUDAMED record Report an error | |
| Aehealth EU representative : MedNet EC-REP GmbH (Germany) | China | – 98/79 | sales@aehealth.com.cn EUDAMED record Report an error | |
| Ailex EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Human | Germany | A IVDR | Website EUDAMED record Report an error | |
| Labnovation EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | Website info@labnovation.com EUDAMED record Report an error | |
| MDX Netherlands Diagnostics EU representative : SUNGO Europe B.V. (Netherlands) | Philippines | A IVDR | EUDAMED record Report an error | |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Shinva FDA EU representative : Eunitor GmbH (Germany) | 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 | |
| ZOVEC diagnostics | Germany |
|
– 98/79 | Website 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) 9
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.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| WATERS TECHNOLOGIES CORPORATION Present in Europe in other categories | – | Acquity | registered |
| Bio-Rad Present in Europe in other categories | United States | D-10 Hemoglobin Variants System VARIANT II TURBO D-100 VARIANT II | K960392 (1996) |
| CEI Pte Ltd | Singapore | – | registered |
| GES Singapore Pte Ltd | Singapore | – | registered |
| Infitek Co., Ltd. Present in Europe in other categories | China | – | registered |
| Labpeak Co.,Ltd | China | – | registered |
| SEKISUI MEDICAL CO., LTD. | Japan | – | registered |
| Scitek Global Co.,Ltd | China | – | registered |
| WATERS CORPORATION Present in Europe in other categories | United States | – | K961557 (1996) |
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