SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.

FDA Device Registration & Listing · SHANTOU Guangdong, CN · Registration 3005202235

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
3005202235
FEI Number
3005202235
Entity Name
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
City/State/Country
SHANTOU Guangdong, CN
Establishment Address
NORTH JINHUAN ROAD, SHANTOU Guangdong 515064, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shantou Wealy Medical Instrument Co., Ltd (Owner Number: 9074040)
Owner / Operator Contact Address
North Jinhuan Road, Shantou, CN-GD 515064, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K203410
PMA Number
N/A

All Registered Proprietary Names

Wealy Syringe Wealy Antistick Syringe Disposable Automatically Retractable Safety Syringes (with detachable needle) Disposable Automatically Retractable Insulin Safety Syringe ENFit Reusable Enteral Syringe Wealy Syringe Sharps Safety Station Needle Counter Box Wealy Syringe Automatically Retractable Safety Syringes with Fixed Needle (1ml, 3ml, 10ml) epidural tray Wealy Syringe ENFit Disposable Enteral Syringe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2005-09-12
MEG Syringe, Antistick General Hospital Class 2 880.5860 2012-03-08
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-12-05
MEG Syringe, Antistick General Hospital Class 2 880.5860 2022-12-05
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2022-12-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-03-23
MEG Syringe, Antistick General Hospital Class 2 880.5860 2022-03-23
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2021-09-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2005-06-10
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2005-06-10
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2011-12-31
MEG Syringe, Antistick General Hospital Class 2 880.5860 2005-06-10
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2005-06-10
MEG Syringe, Antistick General Hospital Class 2 880.5860 2018-11-07
BRY Cabinet, Table And Tray, Anesthesia Anesthesiology Class 1 868.6100 2007-12-28
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2005-08-03
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2021-09-16

Official Correspondent

Clare Yang

US Agent Details

Ruth Wu Business: Kavalan Consulting Inc Email: ruthwu.kavalan@gmail.com Phone: (610) 3102793

Related Public Records

Same Entity

Shantou Wealy Medical Instrument 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
K203410 Shantou Wealy Medical Instrument Co.,Ltd ENFit Disposable Enteral Syringe 2021-06-28
K092413 Inviro Medical Devices, Inc. INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES 2009-09-04
K163162 Jiangxi Hongda Medical Equipment Group , Ltd. Sterile Hypodermic Safety Syringes for Single Use 2017-03-20
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005202235. Last updated year: 2026. Please use registration number 3005202235 when referencing this establishment in official correspondence.
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