Manufacturer

Sinocare

ChinaLegal entities : Changsha Sinocare Inc.

First countries of placing on the market declared in EUDAMED : Cyprus, Czechia, Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, Türkiye

EU representative : SUNGO Europe B.V. (Netherlands)

RA@sinocare.com

11 categories, 25 models including 24 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
Blood glucose meters	W0201060102	FHhub Safe AQ Smart, Safe AQ Voice, Safe AQ Air3 refs Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ max Ⅱ, Safe AQ max Ⅲ98/79 Safe AQ proⅠ98/79 Safe AQ Smart98/79 Safe AQ Voice98/79 5 others Safe-Accu2 refs98/79 Safe-Accu298/79 Safe AQ max Ⅲ98/79 Sinocare Safe-Accu98/79 SLX-120 Lipid and Blood Glucose Analyzer98/79	C IVDR, 98/79	EUDAMED record Report an error
Invasive blood sugar monitoring systems	Z1204011502	GlucoMen® iCan i3, o33 refs GlucoMen® iCan view Glucose Data Reader iCGM-V3 Sinocare iCan i3, o3 Sinocare iCan i6, H6, i7, H72 refs	IIb MDR	EUDAMED record Report an error
General medicine diagnosis and monitoring instruments - medical device software	Z12040192	iCan Review V01 Sinocare iCan Android: V01; iOS: V01	I, IIb MDR	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Safe AQ UG98/79 Sinocare UA101	C IVDR, 98/79	EUDAMED record Report an error
Complete cell count	W0103010103	Hematology Reagent Kit	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Reagent Kit 2N00198/79	– 98/79	EUDAMED record Report an error
Glycosilated hemoglobin devices	W0201060101	Sinocare H102 Air ，H1013 refs	B IVDR	EUDAMED record Report an error
Prothrombin time RT & POC	W0103020801	Prothrombin Time Reagent Kit 1S00198/79	– 98/79	EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other	W0103010199	iCARE-2100	A IVDR	EUDAMED record Report an error
Various diabetes monitoring instruments - other	W020106019099	SLX-121 Lipid and Blood Glucose Analyzer98/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC No model still on the market	W0103020803	Sinocare98/79 (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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