Manufacturer

Xpenarray

ChinaLegal entities : Shenzhen Xpenarray Biotechnology Co., Ltd.

EU representative : CMC Medical Devices & Drugs SL (Spain)

4 categories, 10 models including 0 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) No model still on the market	W0202010101	Automatic 5-Part Hematology Analyzer98/79 (no longer marketed) XN 600098/79 (no longer marketed) XN 610098/79 (no longer marketed) XN 620098/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr) No model still on the market	W0202010102	Automatic Hematology Analyzer IA2005298/79 (no longer marketed) Automatic Hematology Analyzer IA2005398/79 (no longer marketed) XN 650098/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) No model still on the market	W0103010105	XN 3000\XN 3100\XN 3200\XN 33002 refs98/79 (no longer marketed) XN 6000\XN 6100\XN 6200\XN 6300\XN 6500\XN 6600\XN 67003 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Automated 3 part hematology analysers No model still on the market	W0202010201	XN 300098/79 (no longer marketed)	– 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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