Manufacturer

Hebei Xinle Sci&Tech

ChinaLegal entities : Hebei Xinle Sci&Tech Co., Ltd

Markets : Germany · Türkiye · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class II · latest in 2022 · see on the FDA website

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

3 categories, 24 models including 24 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
Blood collection, tubes with additives or serum separator	W050101010201	Single-use Containers for Human Venous Blood Specimen Collection 4NC Sodium Citrate3 refs Single-use Containers for Human Venous Blood Specimen Collection 9NC Sodium Citrate3 refs Single-use Containers for Human Venous Blood Specimen Collection Acid Citrate Dextrose3 refs Single-use Containers for Human Venous Blood Specimen Collection ccfDNA Tube3 refs Single-use Containers for Human Venous Blood Specimen Collection Clot Activator3 refs 10 others Single-use Containers for Human Venous Blood Specimen Collection Gel and Clot Activator3 refs Single-use Containers for Human Venous Blood Specimen Collection Gel and K2EDTA3 refs Single-use Containers for Human Venous Blood Specimen Collection Gel and Lithium Heparin3 refs Single-use Containers for Human Venous Blood Specimen Collection K2EDTA3 refs Single-use Containers for Human Venous Blood Specimen Collection K3EDTA3 refs Single-use Containers for Human Venous Blood Specimen Collection Lithium Heparin3 refs Single-use Containers for Human Venous Blood Specimen Collection Sodium Fluoride/ K2EDTA3 refs Single-use Containers for Human Venous Blood Specimen Collection Sodium Fluoride/ Lithium Heparin3 refs Single-use Containers for Human Venous Blood Specimen Collection Sodium Fluoride/ Potassium Oxalate3 refs Single-use Containers for Human Venous Blood Specimen Collection Sodium Heparin3 refs	A IVDR	EUDAMED record Report an error
Blood collection, capillary tubes	W0501010203	Single-use Containers for Human Capillary Blood Specimen Collection Clot Activator3 refs Single-use Containers for Human Capillary Blood Specimen Collection Gel and Clot Activator3 refs Single-use Containers for Human Capillary Blood Specimen Collection K2EDTA3 refs Single-use Containers for Human Capillary Blood Specimen Collection K3EDTA3 refs Single-use Containers for Human Capillary Blood Specimen Collection Lithium Heparin3 refs 3 others Single-use Containers for Human Capillary Blood Specimen Collection No Additive3 refs Single-use Containers for Human Capillary Blood Specimen Collection Sodium Fluoride/K2EDTA3 refs Single-use Containers for Human Capillary Blood Specimen Collection Sodium Heparin3 refs	A IVDR	EUDAMED record Report an error
Blood collection, tubes without additives or serum separator	W050101010202	Single-use Containers for Human Venous Blood Specimen Collection No Additive3 refs	A IVDR	EUDAMED record Report an error

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