Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014498762

FEI Number

3014498762

Entity Name

HEBEI XINLE SCI&TECH CO.,LTD

City/State/Country

Shijiazhuang City Hebei, CN

Establishment Address

No. 2, Xingye Street, Xinle City, Shijiazhuang City Hebei 050700, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hebei Xinle Sci&Tech Co.,Ltd (Owner Number: 10057534)

Owner / Operator Contact Address

No. 2, Xingye Street, Xinle City, Shijiazhuang City, CN-HE 050700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221839

PMA Number

N/A

All Registered Proprietary Names

XL-B 21G, XL-B 28G, XL-B 30G, XL-C 21G, XL-C 28G, XL-C 30G, XL-E 21G, XL-E 28G, XL-E 30G Lancet VivaGuard SAFETY LANCETS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-07-17

Official Correspondent

Ming Li

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Hebei Xinle Sci&Tech Co.,Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3004525100	SOYAGREENTEC CO.,LTD	Hwaseong-si Gyeonggi, KR
3004468256	SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.	Suzhou City Jiangsu, CN
3010515547	PROMISEMED HANGZHOU MEDITECH CO.,LTD.	Hangzhou Zhejiang, CN
3012172036	TASSO INC	Seattle, WA, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014498762. Last updated year: 2026. Please use registration number 3014498762 when referencing this establishment in official correspondence.