ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD

FDA Device Registration & Listing · WENZHOU Zhejiang, CN · Registration 9615588

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
9615588
FEI Number
3003560965
Entity Name
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD
City/State/Country
WENZHOU Zhejiang, CN
Establishment Address
No.758, 5th Binhai Road Binhai Industrial Park, Longwan, District, WENZHOU Zhejiang 325025, CN
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD (Owner Number: 9036461)
Owner / Operator Contact Address
No.758, 5th Binhai Road Binhai Industrial Park, Longwan District, 325025 Wenzhou, Zhejiang Province PEOPLE'S REPUBLIC OF CHINA, WENZHOU, CN-ZJ 325025, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sol-M Blunt Fill Needle with and without Filter 18Gx1-1/2'' Blunt Needles with and without Filter Blunt Fill Needle with/without Filter Mckesson Blunt Fill Needle Special blunted needle Sterile Hypodermic Needles for Single Use EXEL Multi-Sample Luer Holder Tuohy Needle Quincke Spinal Needle Spinal Needle Anesthesia needles Spinal Anesthesia Needles Luer Lock Syringe with Safety Needle Sterile Hypodermic Needle for Single use Blue End Cap Male/Female Red End Cap Male/Female VitreJect® Syringes VitreJect® Ophthalmic Syringes Disposable Hypodermic Needle EXEL Disposable Hypodermic Needle Sol-M 0.3, 0.5, 1ml Insulin Syringe with fixed needle and 0.5ml, 1ml and 1.5ml TB Syringe w/fixed needle Droplet Insulin Syringe EXEL Scalp Vein Set Blood collecting needle with Holder Blood Collection Needle Safety Needle Holder with Needle Safety Blood Collection Needle Blood Collection Pen Needle Safety Blood Collection Needle with Holder Blood Collection Holder Safety Blood Collection Pen Needle BCS Safety Holder SAFETY BLOOD COLLECTION Blood Collection Tube Holder Luer Adapter With Needle (Male) Safety Multiple Sample Needle Safety Blood Collection Set Safety Blood Collection Needle Preattached Tube Holder Blood Collection Tube Holder Luer Adapter With Needle (Female) Blood Collection Luer Adapter Blood Collecting Needle with Holder Safety Blood collection Set Preattached Holder Safety Blood Collection Winged Set Blood Collecting Needle Safety Blood Collecting Set Blood Transfer Device Luer Lock Access Device Safety Blood Collecting Needle Push Button SafetyBlood Collection Set Sterile Hypodermic Needles for Single Use THIN WALL HYPODERMIC NEEDLE Disposable Needles Sterile Hypodermic Needles Luer Lock Syringe with Exchangeable Needle Luer Lock Syringe with Safety Needle NEELE,HYPODERMIC, SINGLE LUMEN Sol-Care Safety Needle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2018-03-14
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-11-07
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2024-12-18
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2020-11-13
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2016-09-21
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2019-11-29
QNQ Low Dead Space Piston Syringe General Hospital Class 2 880.5860 2026-01-29
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2017-12-25
GCE Adaptor, Catheter General, Plastic Surgery Class 1 878.4200 2019-10-24
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-09-19
QLY Ophthalmic Syringe General Hospital Class 2 880.5860 2024-09-19
QNQ Low Dead Space Piston Syringe General Hospital Class 2 880.5860 2024-09-19
FMF Syringe, Piston General Hospital Class 2 880.5860 2008-02-05
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2016-09-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-04-27
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-04-27
MEG Syringe, Antistick General Hospital Class 2 880.5860 2026-04-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2018-03-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-06-27
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2018-10-29
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2025-05-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-05-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-03-20
MEG Syringe, Antistick General Hospital Class 2 880.5860 2025-02-13
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-02-13
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-02-13
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2014-04-02
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-03-02

Official Correspondent

ZHANG WEIXIN

US Agent Details

Richard Chun Business: The Wood Burditt Group Email: rchun@woodburditt.com Phone: (847) 2347500

Related Public Records

Same Entity

ZHEJIANG KINDLY MEDICAL DEVICES 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
K781371 Ferris Mfg. Corp. BONE MARROW ASPIRATION KIT 1978-09-20
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
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
K943349 Quinton, Inc. MAHURKAR DUAL LUMEN CATHETER 1995-03-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
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
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

Similar Registrations

Registration Number Establishment Name Location
3029952419 DIAMINY MEDICAL AESTHETICS Shanghai, CN
3020664622 Pneumeric, Inc. Luverne, MN, US
3005748921 ISCON SURGICALS, LTD. JODHPUR Rajasthan, IN
9616662 MERIT MEDICAL IRELAND, LTD Galway, IE
2029275 Sterigenics U.S., LLC Corona, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615588. Last updated year: 2026. Please use registration number 9615588 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.