Manufacturer

Wheisman Medical Technology

ChinaLegal entities : Wheisman Medical Technology Co., Ltd.

Markets : Germany · Netherlands

Approvals : EU – class A

EU representative : Umedwings Netherlands B.V. (Netherlands)

5 categories, 26 models including 26 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Hematology Reagent - Diluent 2L, 5L, 10L, 20L3 refs Hematology Reagent - Diluent W-31D：2L, 5L, 10L, 20L3 refs Hematology Reagent - Lyse W-31L：250mL、250mL×3、500mL、500mL×3、1L3 refs Hematology Reagent - Lyse W-61LD：250mL、250mL×3、500mL、500mL×3、1L3 refs Hematology Reagent - Lyse W-61LH：250mL、250mL×3、500mL、500mL×3、1L3 refs 4 others Hematology Reagent - Lyse W-62LD： 250mL, 500mL, 500mL×4, 1L 1L×43 refs Hematology Reagent - Lyse W-63LD1： 200mL, 500mL, 1L, 1L×43 refs Hematology Reagent - Lyse W-63LD2： 100mL, 250mL, 500mL, 500mL×43 refs Hematology Reagent - Probe Cleanser 50mL、50mL×22 refs	A IVDR	EUDAMED record Report an error
Multilevel blood controls	W0103010503	Hematology Control L-3D： High: 2.5mL/Vial98/79 Hematology Control L-3D： Mix: 2.5mL/Vial98/79 Hematology Control L-3D：Low: 2.5mL/Vial98/79 Hematology Control L-3D：Normal: 2.5mL/Vial98/79 Hematology Control L-5D：High: 3mL/Vial98/79 3 others Hematology Control L-5D：Low: 3mL/Vial98/79 Hematology Control L-5D：Mix: 3mL/Vial98/79 Hematology Control L-5D：Normal: 3mL/Vial98/79	– 98/79	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Auto 3-part Hematology Analyzer AC 31098/79 Auto 3-part Hematology Analyzer AC31698/79 Auto 3-part Hematology Analyzer AC33098/79 Auto 3-part Hematology Analyzer AC33698/79 Auto 5-part Hematology Analyzer AC 61098/79 1 other Auto 5-part Hematology Analyzer AC 63098/79	– 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Auto 5-part Hematology Analyzer AC 61698/79 Auto 5-part Hematology Analyzer AC 63698/79	– 98/79	EUDAMED record Report an error
Whole blood calibrators	W0103010507	Hematology Calibrator L-CAL：3mL×198/79	– 98/79	EUDAMED record Report an error

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