Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015955792

FEI Number

3015955792

Entity Name

SANDSTONE MEDICAL (SUZHOU) INC.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Building 6, No.168 PuTuoShan Road, New District, Suzhou Jiangsu 215153, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sandstone Medical (Suzhou) INC. (Owner Number: 10080666)

Owner / Operator Contact Address

Building 6, No.168 PuTuoShan Road, New District, Suzhou, CN-JS 215153, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193422

PMA Number

N/A

All Registered Proprietary Names

Easydrip Plus Pen Needle Easydrip Classic Pro Pen Needle Easydrip Plus Pro Pen Needle Easydrip Classic Pen Needle Easydrip Easydrip Plus Pen Needle Pen needle 32Gx6mm Pen needle 30Gx5mm Embrace® Pen Needles Sitesmart Pen Needles Rapha Pen Needles SOL.M Pen Needles Mckesson Pen Needles GLUCO-CARE PLUS Pen Needle GLUCO-CARE Classic Pen Needle ONE-CARE Pen Needle EveryMeds Pen Needles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-03-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-02-18

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

Sandstone Medical (Suzhou) INC.

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015955792. Last updated year: 2026. Please use registration number 3015955792 when referencing this establishment in official correspondence.