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Hebei Xinle Sci&Tech Co., Ltd.

China·CN-MF-000016692

Last updated May 30, 2026

What Hebei Xinle Sci&Tech Co., Ltd. makes

The company manufactures single-use manual blood lancing devices designed for capillary blood collection, alongside sterile containers specifically for human capillary blood specimen collection. These containers are intended for one-time use in clinical or home testing environments to ensure sample integrity and safety.

The portfolio includes devices classified as Class A, Class I, Class II, and Class IIa under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: China
Address: No.2, No.2, Xingye Street, Xinle City, Shijiazhuang City, Hebei Province, China
Website: hbxinle.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-15097339955
PRRC Contact: Dandan Hu
EUDAMED SRN: CN-MF-000016692
FDA FEI Number: —
DUNS Number: 529813593

Catalogue (245)

Page 3 of 5

Device	Model / Reference	Registries	Class	Status
Lancet	XLB2622	EUDAMED	Class IIa	Active
Lancet	XLD2128	EUDAMED	Class IIa	Active
Lancet	XLB2120	EUDAMEDFDA UDI	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-GH35	EUDAMED	Class A	Active
xinle	XLPII20C	EUDAMED	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPB-A55	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-LH10	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-NR1	EUDAMED	Class A	Active
Lancet	XLD2118	EUDAMED	Class IIa	Active
xinle	XLIII25	EUDAMED	Class IIa	Active
Lancet	XLB2820	EUDAMEDFDA UDI	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-NR2	EUDAMED	Class A	Active
GLUCO-CARE Safety Lancets	XLII2318	EUDAMED	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-NR3	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-FX4	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-C3	EUDAMED	Class A	Active
xinle	XLPI22D	EUDAMED	Class IIa	Active
Lancet	XLD2116	EUDAMED	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-LH8	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-GH7	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-GK8	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-GK3	EUDAMED	Class A	Active
xinle	XLPII20D	EUDAMED	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-A4	EUDAMED	Class A	Active
Lancet	XLE2816	EUDAMED	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-CF9	EUDAMED	Class A	Active
Lancet	XLD2628	EUDAMED	Class IIa	Active
Lancet	XLII2318	EUDAMED	Class IIa	Active
xinle	XLPII18B	EUDAMED	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-GK85	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-CF8	EUDAMED	Class A	Active
Lancet	XLE2818	EUDAMEDFDA UDI	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-FH5	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-NH5	EUDAMED	Class A	Active
Lancet	XLB3022	EUDAMEDFDA UDI	Class IIa	Active
Lancet	XLB3020	EUDAMEDFDA UDI	Class IIa	Active
Venous Blood Collection Needles	XLPII22D	EUDAMED	Class IIa	Active
Venous Blood Collection Needles	XLPI22D	EUDAMED	Class IIa	Active
xinle	XLII2618	EUDAMED	Class IIa	Active
Lancet	XLIII27	EUDAMED	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-E3K9	EUDAMED	Class A	Active
Venous Blood Collection Needles	XLPII21D	EUDAMED	Class IIa	Active
Lancet	XLD2316	EUDAMED	Class IIa	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-E3K1	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-GH8	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-NR9	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPC-GC7	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-NR4	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPA-4SC16	EUDAMED	Class A	Active
Single-use Containers for Human Venous Blood Specimen Collection	XLSPB-NR7	EUDAMED	Class A	Active

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Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

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