ZHEJIANG LIDESEN MEDICAL INSTRUMENT CO., LTD

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3031184338

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
3031184338
FEI Number
3031184338
Entity Name
ZHEJIANG LIDESEN MEDICAL INSTRUMENT CO., LTD
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
A-1931, Building 3, No. 228 Binkang Road, Xixing Street, Binjiang District, Hangzhou Zhejiang 310052, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Zhejiang Lidesen Medical Instrument Co., Ltd (Owner Number: 10090389)
Owner / Operator Contact Address
A-1931, Building 3, No. 228 Binkang Road, Xixing Street, Binjiang District, Hangzhou, CN-ZJ 310052, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Needle Holder Dressing set TYPE S9 - Sterile Adult Diaper,Baby Diaper,Pet Diaper,Pull-Up Diaper Underpad,Pet Pad,Nursing Pad Lignin Pads / Cellulose Absorbent Pads digital Thermometer covers Alginate Dressing,FOAM DRESSING Set,Hydrophilic Dressing Surgeon Gown,Exam Gown Nasal Oxygen Cannula DENTAL BIBS Absorbent Cotton Roll, Zig-Zag Cotton Wool, Cotton Pad, Cotton Ball Absorbent cotton pad -NCP , non-woven cotton pad,no-sterile and sterile sterile suture removal set (scissors, forceps & gauze) STOCKING, MEDICAL SUPPORT Isolation Gown, Lab Coat, Coverall, PE Gown Bedsheet, Bed Cover,BODY BAG, Emergency Blanket Nail Brush/Surgical brush sterile, natural, with nail cleaner Syringe, Irrigation non sterile urine bags Oxygen Mask,Non-Rebrething Mask SALIVA EJECTOR BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE Ostomy Bag PE Apron, CPE Apron, PVC Apron, Non-Woven Apron Tipped Applicator, Cotton Swabs, Cottton Buds Non-sterile Cotton wooden applicator/swabs Non-sterile Cotton Plastic applicator/swabs ORTHOSIS, LIMB BRACE Mydriatic Eyewear) - Disposable Goggles, Face Guard, Face Shield Urinal Plaster Of Paris Bandage, Undercast Padding Sterilization paper bag; Sterilization wrap, plain, paper; Autoclave tape with indicator strip Cold Pack,Hot Pack,Hot/Cold Pack,Cooling Gel Patch Nebulizer Mask, Simple Oxygen Mask Micro Pipette Examination nitrile gloves Copolymer naylon Examination Gloves sterile SURGICAL DRAPES, SURGICAL DRAPES WITH HOLE ORTHOSIS, LUMBO-SACRAL Orthosis, Cervical Staple extrcator - Sterile IMP Device, Urine Flowrate Measuring, Non-Electrical, Disposable SKIN CLOSURE Nasopharyngeal/Nasal Airway Laryngeal Mask Airway,Guedel Airway,Nasal Airway NASAL TUBING UNIVERSAL Guedel Airway (Oral) Sterile Cotton wooden applicator/swabs, Sterile Cotton Plastic applicator/swabs Basin, Emesis Surgical Scissor small - Black Handles Film Dressing, I.V. DRESSING SUCTION YANKAUER, SUCTION CATHETER combi cap, Red color; Heperin cap, Site injection, Yellow connector, sterile, heparin lock Sanitary Napkin Shoe Cover,Boot Cover, Sleeve Cover VAGINAL SPECULUM First Aid Bag, First Aid Kit; Instrument Cases/First Aid Case/Plastic Case urine bottle plastic with cover with graduation urine bottle False tooth boxes with colander insider white EYE PAD ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB Tweezers,Forceps ORTHOSIS, LUMBAR Tongue Depressor JOINT, KNEE, EXTERNAL BRACE Mouth to Mouth Face Shield CPR Mask, Non-invasive Positive Pressure Ventilation Mask, CPAP Mask, Trachesotomy Mask, Silicone Mask, Anesthesia Mask Container, Specimen, Sterile Endotracheal tube Gauze Swabs With X-Ray,Gauze Balls With X-Ray, Gauze Bandage With X-Ray,Gauze Roll With X-Ray; Gauze Zig-Zag With X-Ray,Gauze Cutting With X-Ray,Lap Sponges With X-Ray Super Absorbency Dressing; Ultra Thin Absorbent Film Foam Dressing; Hydrocolloid Dressing; Hydrocolloid Foam Dressing; Nonwoven Wound Dressing; Silicone Dressing; Adjustable Mask; Venturi Mask Alcohol Prep Pad,Alcohol Swabs, Povidone-Iodine Pad,BZK Antiseptic Pad, Antiseptic Cleaning Wipe Adhesive Tape, Elastic Adhesive Bandage, Cohesive Bandage, Kinesiology Tape, Silicone Tape NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) Triangular Bandage,Arm Sling Elastic Bandage,Tubular Bandage TUBE, ASPIRATING, FLEXIBLE, CONNECTING,Yankauer Handle COVERSLIPS,MICROSCOPE SLIDE Anti-Leakage Strip; Hydrocolloid Skin Barrier; Hydrocolloid Skin Protective Ring;; Protective Dressing Wipe;; Skin Prote Dish, Tissue Culture TOURNIQUET ID Bracelet; Identification Band HYDROCOLLOID FOAM DRESSING; HYDROGEL DRESSING Sterile vazalin pad-10X10 10 p Gauze Swabs,Gauze Balls,Gauze Bandage,Gauze Roll,Gauze Zig-Zag, Gauze Cutting, Lap Sponges Test Tube Suction Catheter,TRACHEOBRONCHIAL Tube Slides,Microscope SPECIMEN CONTAINER, URINE CONTAINER, STOOL CONTAINER 3-Ply Face Mask; Disposable Surgical Mask; KN95 Mask; Non-Woven Face Mask Non-woven Face Mask (Earloops Type) 2ply 3ply; Non-woven Face Mask (Ties Type) 2ply 3ply

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KST System, Blood Collection, Vacuum-Assisted, Manual Hematology Class 1 864.9125 2026-06-07
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2025-02-16
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2024-03-24
NTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) General Hospital Class 1 880.5630 2024-03-24
JEW Tip, Rubber, Oral Hygiene Dental Class 1 872.6650 2025-04-03
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2024-03-24
FME Gown, Examination General Hospital Class 1 880.6265 2024-03-24
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2024-03-24
KHR Absorber, Saliva, Paper Dental Class 1 872.6050 2024-03-24
EFN Cotton, Roll Dental Class 1 872.6050 2024-03-23
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2025-06-20
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2024-03-24
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2024-03-24
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2024-03-24
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2025-08-26
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2024-03-24
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2025-11-26
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2024-03-24
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2024-03-24
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2024-03-24
FON Bag, Drainage, With Adhesive, Ostomy Gastroenterology, Urology Class 1 876.5900 2024-03-24
IWO Apron, Protective Radiology Class 1 892.6500 2024-03-24
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2024-03-24
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2024-03-24
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2024-03-24
FNP Urinal General Hospital Class 1 880.6730 2024-03-24
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2024-03-23
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2026-05-06
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2024-03-24
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2024-03-24
JRC Micro Pipette Clinical Chemistry Class 1 862.2050 2024-03-24
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2025-02-16
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2024-03-24
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2024-03-24
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2025-02-16
FFG Device, Urine Flow Rate Measuring, Non-Electrical, Disposable Gastroenterology, Urology Class 2 876.1800 2024-03-24
MKY System, Skin Closure General, Plastic Surgery Class 1 878.4320 2024-03-24
BTQ Airway, Nasopharyngeal Anesthesiology Class 1 868.5100 2024-03-24
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2025-11-26
FNY Basin, Emesis General Hospital Class 1 880.6730 2024-03-24
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2025-02-16
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2024-03-24
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2024-03-24
JJG Analyzer, Chemistry, Centrifugal, For Clinical Use Clinical Chemistry Class 1 862.2140 2025-02-16
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2024-03-24
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2024-03-24
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2024-03-24
OHO First Aid Kit Without Drug General, Plastic Surgery Class 1 878.4014 2024-03-24
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2025-02-16
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 2025-02-16
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2024-03-24
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2024-03-24
HTD Forceps General, Plastic Surgery Class 1 878.4800 2024-03-24
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2024-03-24
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2024-03-24
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2024-03-24
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2024-03-24
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2024-03-24
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2025-11-26
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2024-03-23
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2024-03-24
BYF Mask, Oxygen, Low Concentration, Venturi Anesthesiology Class 1 868.5600 2024-03-24
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2024-03-24
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2024-03-23
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2024-03-24
ILI Sling, Arm Physical Medicine Class 1 890.3640 2024-03-24
FQM Bandage, Elastic General Hospital Class 1 880.5075 2024-03-21
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2024-03-24
KES Coverslips, Microscope Slide Pathology Class 1 864.3010 2024-03-24
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2024-03-24
KIZ Dish, Tissue Culture Hematology Class 1 864.2240 2024-03-24
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2024-03-24
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2024-03-24
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2024-03-24
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2024-03-23
KJG Tube, Tissue Culture Pathology Class 1 864.3010 2024-03-24
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2024-03-24
KEW Slides, Microscope Pathology Class 1 864.3010 2024-03-24
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2024-03-24
QKR Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Unknown Class N N/A 2024-03-24

Official Correspondent

Xiaodong Liu

US Agent Details

Sam Shi Business: Medwin Inc. Email: MedwinInc@Aliyun.Com Phone: (626) 2651595

Related Public Records

Same Entity

Zhejiang Lidesen 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
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20
K823241 Kimberly-Clark Corp. NEW FREEDOM THIN UNSCENTED MAXI PADS 1982-12-28
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02

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Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0006-2025 Ossur H F Grjothals 5 Reykjavik Iceland 1
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0007-2013 Invuity, Inc. 2
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031184338. Last updated year: 2026. Please use registration number 3031184338 when referencing this establishment in official correspondence.
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