Manufacturer

Seamaty

ChinaLegal entities : Chengdu Seamaty Technology Co.,Ltd, Seamaty Diagnostic Co., Ltd., Seamaty Diagnostic Technology (Chengdu) Co., Ltd.

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

EU representative : MedNet EC-REP GmbH (Germany)

12 categories, 31 models including 31 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
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Category	EMDN code	Registered models	Class	Contact
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	Auto Chemistry Analyzer SMT-10A Auto Chemistry Analyzer SMT-120 Auto Dry Biochemistry Analyzer SD1 Auto Dry Biochemistry Analyzer SD1080 Auto Dry Biochemistry Analyzer SD3 5 others Seamaty SD1、SD32 refs Seamaty SMT-120 Semi-automatic Biochemistry Analyzer SMT-70 Semi-automatic Biochemistry Analyzer SMT-70A VCHEMY S® EVO EVO-A01	A IVDR	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Cleaner SMT-5C(50ml/200mL)2 refs Diluent SMT-3D（5L、10L、20L）3 refs Diluent SMT-5D(5L、10L、20L)3 refs Lyse SMT-3L（50ml、100mL、 200ml、250ml 、500mL、1L）3 refs Lyse SMT-5L-D（50ml、100mL、 200ml、250ml 、500mL、1L）3 refs 1 other Lyse SMT-5L-H（50ml、100mL、 200ml、250ml 、500mL、1L）3 refs	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Automatic Hematology Analyzer SMT-30 Automatic Hematology Analyzer SMT-30 Pro Automatic Hematology Analyzer SMT-50 Automatic Hematology Analyzer SMT-60	A IVDR	EUDAMED record Report an error
BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)	W0201040102	Seamaty SG1 VEGA-001	A IVDR	EUDAMED record Report an error
Blood gas analysers - with classic profile (pH, PO2, PCO2, hct + electrolytes)	W0201040101	Blood gas & Electrolyte Analyzer SG1 POCT Electrolyte Analyzer SE1	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Fully Automated Chemiluminescence Immunoassay Analyzer SC200	A IVDR	EUDAMED record Report an error
Blood gas analysis / electrolyte instruments - other	W02010499	Blood gas & Electrolyte Analyzer SG1	A IVDR	EUDAMED record Report an error
Blood gas portable analysers	W0201069002	VEGA-001	A IVDR	EUDAMED record Report an error
Haematology rapid tests & point of care - other	W0103010699	Kit for Morphology Analyzer	A IVDR	EUDAMED record Report an error
Ion selective electrolyte analysers	W0201040201	Seamaty SE1	A IVDR	EUDAMED record Report an error
Rapid test cell count instruments	W02020601	AI Morphology analyzer SA1	A IVDR	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	VCHEMY S® EVO EVO-A01	A IVDR	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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