Manufacturer

Konsung

ChinaLegal entities : Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd., Jiangsu Konsung Medical Technology Co., Ltd.

First countries of placing on the market declared in EUDAMED : Austria, Belgium, Germany, Italy, Netherlands

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

info@konsung.com

15 categories, 59 models including 59 on the market, 1 country

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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
Pulse oximeters	Z1203020408	konsung SONOSAT-K01R, SONOSAT-K02R, SONOSAT-K01SR, SONOSAT-K02SR, SONOSAT-K01W, SONOSAT-K02W, SONOSAT-K01SW, SONOSAT-K02SW, SONOSAT-K01T, SONOSAT-K02T, SONOSAT-K01LT, SONOSAT-K02LT, SONOSAT-K01P, SONOSAT-K02P, SONOSAT-K01LP, SONOSAT-K02LP SONOSAT-F01LP93/42 SONOSAT-F01LT93/42 SONOSAT-F01LW93/42 SONOSAT-F01P93/42 13 others SONOSAT-F01W93/42 SONOSAT-F02LP93/42 SONOSAT-F02LT93/42 SONOSAT-F02LW93/42 SONOSAT-F02P93/42 SONOSAT-F02T93/42 SONOSAT-F02W93/42 SONOSAT-W01LP93/42 SONOSAT-W01LT93/42 SONOSAT-W01LW93/42 SONOSAT-W01P93/42 SONOSAT-W01T93/42 SONOSAT-W01W93/42	IIa MDR, 93/42	EUDAMED record Report an error
Oxygen concentrators	Z12159004	konsung SONOSAT-F01T93/42 KSN-593/42 KSOC-1093/42 KSOC-593/42 KSW-593/42 7 others KSW-5,KSJ-5,KSI-5,KSQ-53 refs Oxygen concentrator Oxygenate 5 (KSW-5)93/42 Oxygen concentrator Oxygenate 5（konsung：KSW-5 ）93/42 oxygenate KSOC-10 （230V 50Hz）93/42 Oxygenate KSW-593/42 oxygenate KSW-5 (220V, 50Hz, Philips）93/42 philips KSOC-102 refs93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Multi-parameter patient bedside monitors	Z1203020201	AURORA 1093/42 AURORA 10s93/42 AURORA 1293/42 AURORA 12s93/42 AURORA 893/42 1 other AURORA 8s93/42	IIa, IIb 93/42	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	COVID-19 Antigen Rapid Test Kit (Colloidal Gold)3 refs98/79 COVID-19 Antigen Rapid Test Kit（Colloidal Gold） -for self-testing2 refs98/79 COVID-19 Neutralizing Antibodies Rapid Test Kit (Colloidal Gold)3 refs98/79 COVID-19 Neutralizing Antibody Rapid Test Kit (Immunofluorescence Method)98/79 COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold)2 refs98/79 1 other Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold)2 refs98/79	– 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Compass2000-1, Compass2000-22 refs Compass2800-1, Compass2800-22 refs Compass3000-1, Compass3000-22 refs	A IVDR	EUDAMED record Report an error
Vital signs monitoring instruments - other	Z12030299	HES-393/42 HES-593/42 HES-793/42	IIa 93/42	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Helicobacter pylori Antibody (IgG) Test Kit (Colloidal Gold)98/79 Helicobacter pylori Antigen Test kit (Colloidal Gold)2 refs98/79	– 98/79	EUDAMED record Report an error
Semi-automated hematology analysers	W0202010202	Konsung WBC-298/79 Konsung WBC-598/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	D-Dimer Test Kit (Immunofluorescence Method)98/79	– 98/79	EUDAMED record Report an error
Haemoglobin controls	W0103010504	HBC-3A3 refs98/79	– 98/79	EUDAMED record Report an error
Histo / cyto stains	W0103010301	Konsung C1013 refs	A IVDR	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A&B Rapid Test Kit (Colloidal Gold)2 refs98/79	– 98/79	EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - other	W02020699	Konsung H7-1，H7-2，H7-33 refs	B IVDR	EUDAMED record Report an error
Samples collection devices - other	W05019099	HB-013 refs	A IVDR	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	HCU01, HCU022 refs	A IVDR	EUDAMED record Report an error

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