Sterilance Medical (Suzhou) Inc.

FDA Device Registration & Listing · Suzhou Jiangsu, CN · Registration 3014649053

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014649053
FEI Number
3014649053
Entity Name
Sterilance Medical (Suzhou) Inc.
City/State/Country
Suzhou Jiangsu, CN
Establishment Address
No.168 PuTuoShan Road, New District, Suzhou Jiangsu 215153, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Sterilance Medical (Suzhou) Inc. (Owner Number: 9070037)
Owner / Operator Contact Address
No.168 PuTuoShan Road, New District, SUZHOU, CN-JS 215133, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Blades Skin Graft Knife Blade Blade Arm Achilles Stitch Cutter Asurity Skin Graft Gouge Standard SS Standard CS Disposable surgical blades Safety Blades Index Asurity MEDLINE Adjustable Depth Safety Lancets Press2 Press Flex3 Press Plus Safety Pressure Activated Lancets Press2 Plus SENSILANCE™ BUTTON ACTIVATED SAFETY LANCETS Lite3 Embrace® Pressure Activated Safety Lancets UltraLANCE™ Sterile Safety Lancets Index Asurity Safety Handle Twist Lancets Embrace® Blood Glucose Sterile Lancets OneTouch UltraSoft2 Soft KetoBM Sterilized Lancets suttersync™ Soft Disposable Blood Lancet WALG LANCETS Sinodraw® Soft Disposable Blood Lancet Disposable steel lancet Twist lancets PA Clix MiniCollect PIXIE ice bag SteriHeel 2 Blueline™ Heel Incision Safety Lancets Neoheel SteriHeel Plus SteriHeel Safety-Heel®Newborn Safety-Heel®Preemie MiniCollect® PIXIE Heel Incision Safety Lancet Heel Incision Device McKesson PREVENT® Heel Incision Devices NEWBORN Heel Plus OctaHeel KBMED™ Heel Incision Safety Lancet SteriLance Lancing Device LDE 4-AST LDE4 LDE4 AST LDE AST NanoSense OneStep LDE NANOSense™ Lancing Device suttersync™ Lancing Device Elite Lite4 Impress Pro Disposable safety lancet Elite Disposable safety lancet Elite Pro Elite Pro One-Care PRO Safety Lancets One-Care COMFORT Safety Lancets Impress LMP DIAGNOSTICS™ Disposable Safety Lancets Safety Protected blade System Index handle Scalpel Mini Disposable Scalpel Disposable Safety Scalpel Standard Mini Standard II Asurity Cartridge Asurity Safety I Standard I Safety Blades Index Asurity Soft Disposable Blood Lancet Easydrip Disposable Insulin Needle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2013-12-30
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-11-01
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2014-05-12
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-09-01
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2026-02-27
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2003-11-26
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2016-08-12
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-03-03
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-04-18
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-02-02
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2022-08-31
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2024-01-18
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2005-02-02
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2026-06-15
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2016-08-31

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

Sterilance 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
K130132 Medipurpose Pte. , Ltd. BABYLANCE HEEL INCISION DEVICE 2013-02-11
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
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
Z-0039-2018 Teleflex Medical 1
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
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 3014649053. Last updated year: 2026. Please use registration number 3014649053 when referencing this establishment in official correspondence.
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