FDA Registration Active 🇨🇳 China

JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD.

Reg #: 3015058854 · FEI: 3015058854 · Expires 2026
Products
140
Proprietary Names
152
Establishment Types
1
Classifications
140

Registration Details

Registration Name
JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD.
Registration Number
3015058854
FEI Number
3015058854
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Rm.1101 Blvd.#1, Tianning Shidai Plaza
City
Changzhou Jiangsu
Country
CN

Regulatory Submissions

510(k) Number
K212120

Owner / Operator

Firm Name
New Pentastar Medical Products Co. Limited
Operator Number
10063374
Address
FLAT C 9/F Winning House 72-76 Wing Lok Street, Sheung Wan
City
HK
State
HK-NOTA
Postal Code
999077
Country
HK
Correspondent
Owen Luo

US Agent

Business Name
BRIDON CORP
Contact Name
Mel Torres
Address
3 Calle Campeche
City
Carolina
State
PR
ZIP
00987
Country
US
Phone
787 4554150

Products

Device Name Product Code
Laparoscopy Kit FDE
Kit, Surgical Instrument, Disposable KDD
Catheter And Tip, Suction JOL
Mask, Surgical FXX
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
Tray, Surgical, Instrument FSM
Cannula, Nasal, Oxygen CAT
Fiber, Medical, Absorbent FRL
Wound Dressing With Animal-Derived Material(S) KGN
Walker, Mechanical ITJ
First Aid Kit Without Drug OHO
Cap, Surgical FYF
Crutch IPR
Basin, Emesis FNY
Bandage, Elastic FQM
Container, Specimen, Sterile FMH
Stethoscope, Manual LDE
Stand, Infusion FOX
Syringe, Irrigating (Non Dental) KYZ
Silicone Hydrogel For Scar Management PFP
Device, Paste-On For Incontinence, Non-Sterile NOA
Mask, Oxygen BYG
Exerciser, Non-Measuring ION
Shield, Protective, Personnel KPY
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Needle, Hypodermic, Single Lumen FMI
Gown, Surgical FYA
Brush, Cleaning, Tracheal Tube EPE
Pad, Alcohol, Device Disinfectant LKB
Support, Patient Position CCX
Drape, Microscope, Ophthalmic HMW
Catheter, Irrigation GBX
Device, Fixation, Tracheal Tube CBH
Aid, Transfer IKX
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Dressing, Compression MHW
Container, Specimen, Non-Sterile NNI
Counter, Sponge, Surgical LWH
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
Drape, Surgical, Exempt PUI
Fentanyl And Other Opioid Protection Glove QDO
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
Medical Glove, Specialty LZC
Polymer Patient Examination Glove LZA
Mask, Oxygen, Low Concentration, Venturi BYF
Cup, Prophylaxis EHK
Syringe, Piston FMF
Nebulizer (Direct Patient Interface) CAF
Accessories, Catheter KGZ
Sling, Arm ILI
Bedding, Disposable, Medical KME
Collector, Urine, (And Accessories) For Indwelling Catheter KNX
Dressing, Wound, Hydrophilic NAC
Dressing, Wound, Drug FRO
Enema Kit FCE
Shoe And Shoe Cover, Conductive BWP
Container, Specimen Mailer And Storage, Non-Sterile NNK
Needle, Catheter GCB
Mattress, Air Flotation, Alternating Pressure FNM
Cane IPS
Airway, Oropharyngeal, Anesthesiology CAE
Non-Surgical Gown OEA
Depressor, Tongue, Non-Surgical FMA
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Infusor, Pressure, For I.V. Bags KZD
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
Personal Protection Kit PXC
Catheter, Nasal, Oxygen BZB
Tips And Pads, Cane, Crutch And Walker INP
Tubing, Noninvasive GAZ
Solvent, Adhesive Tape KOX
Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
Disinfectant, Medical Devices LRJ
Speculum, Non-Illuminated FXE
Tube, Tracheal (W/Wo Connector) BTR
Chair, With Casters INM
Calculator/Data Processing Module, For Clinical Use JQP
System, Test, Blood Glucose, Over The Counter NBW
Glucose Oxidase, Glucose CGA
Mask, Oxygen, Non-Rebreathing KGB
Catheters, Suction, Tracheobronchial BSY
Light, Surgical, Accessories FTA
Cover, Mattress (Medical Purposes) FMW
Electrode, Electrocardiograph DRX
Drape, Adhesive, Aerosol KGT
Set, Administration, Intravascular FPA
Wheelchair, Mechanical IOR
Suture Removal Kit MCZ
Closure, Wound, Adhesive MGO
Bag, Reservoir BTC
Device, Paste-On For Incontinence, Sterile EXI
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Dispenser, Solid Medication NXB
Airway, Nasopharyngeal BTQ
Accessory, Surgical Apparel LYU
Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
Marker, Skin FZZ
Container, Sharps MMK
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Catheter, Ventricular, General & Plastic Surgery GBS
Urinal FNP
Bandage, Cast ITG
Chair And Table, Medical KMN
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Continuous Measurement Thermometer FLL
Bag, Urine Collection, Leg, For External Use, Sterile FAQ
Mask, Gas, Anesthetic BSJ
Applicator, Absorbent Tipped, Sterile KXG
Absorber, Saliva, Paper KHR
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
Cover, Shoe, Operating-Room FXP
Strip, Adhesive, Closure, Skin FPX
Dressing, Wound, Occlusive NAD
Tourniquet, Nonpneumatic GAX
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
Multiple Use Blood Lancet For Single Patient Use Only QRL
First Aid Kit With Drug LRR
Pack, Hot Or Cold, Disposable IMD
Gown, Examination FME
Gauze/Sponge, Internal, X-Ray Detectable GDY
Garment, Protective, For Incontinence EYQ
Orthosis, Lumbar IQE
System, Measurement, Blood-Pressure, Non-Invasive DXN
Respirator, Surgical MSH
Bedpan FOB
Glucose Dehydrogenase, Glucose LFR
General Surgery Tray LRO
Tracheostomy And Nasal Suctioning Kit LRQ
Restraint, Protective FMQ
Speculum, Vaginal, Nonmetal HIB
System, Blood Collection, Vacuum-Assisted, Manual KST
Wrap, Sterilization FRG
Tape And Bandage, Adhesive KGX
Lubricant, Patient KMJ
Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
Apron, Protective IWO
Gauze / Sponge,Nonresorbable For External Use NAB
Stocking, Medical Support (For General Medical Purposes) FQL
Tube, Aspirating, Flexible, Connecting BYY
Brush, Scrub, Operating-Room GEC

Proprietary Names

laparoscopy kit Central Line Trays; Convenience Kits; Dressing change kit; instrument pack; Irrigation tray; IV START KIT; Laceration Tray; Shave Prep Kit; skin scrub Tray; Tracheostomy Care Tray CATHETER AND TIP, SUCTION Mask, surgical, Face mask, Surgical masks, Urinary drainage collection kit, for indwelling catheter TRAY, SURGICAL, INSTRUMENT ASAL OXYGEN CANNULA, OXYGEN CANNULA OR Towel, Gauze, Wipes Collagen Wound Dressing Walker, mechanical First aid kit without drug CAP, SURGICAL, Bouffant Caps, clip caps CRUTCH BASIN, EMESIS BANDAGE, ELASTIC, Cohesive Bandage; ESMARK BANDAGE,Conforming Bandage, Elastic Crepe Bandage CONTAINER, SPECIMEN, STERILE STETHOSCOPE, MANUAL STAND, INFUSION SYRINGE, IRRIGATING (NON DENTAL), IRRIGATOR Silicone hydrogel for scar management DEVICE, PASTE-ON FOR INCONTINENCE, NON-STERILE MASK, OXYGEN EXERCISER, NON-MEASURING Isolation Face Shield, Isolation Face Mask, Medical Face Shield, Medical Shield, Face Shield Luer Access Device-holder with Preattached Multiple Sample Adapter Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Surgical gown BRUSH, CLEANING, TRACHEAL TUBE Pad, alcohol, device disinfectant SUPPORT, PATIENT POSITION Drape, microscope, ophthalmic CATHETER, IRRIGATION Device, fixation, tracheal tube AID, TRANSFER Circuit, breathing (w connector, adaptor, y piece) dressing, compression CONTAINER, SPECIMEN, NON-STERILE Counter, sponge, surgical Stocking, medical support (to prevent pooling of blood in legs) Drape, surgical, exempt Powder Free Nitrile Examination Glove MASK, OXYGEN, LOW CONCENTRATION, VENTURI Dental cup, Denture Cup Syringe, piston NEBULIZER BOTTLE SET ACCESSORIES, CATHETER, CATHETER HOLDER, CATHETER STRIP SLING, ARM bedding, disposable, medical - BED COVERS; BED SHEETS; NON WOVEN BEDSHEETS/COVERS; PILLOW CASES Urine (And Accessories) For Indwelling catheter, Urinary drainageBag hold collector, urine, (and accessories) for indwelling catheter - BAG, URINARY LEG W/STRAPS, LEG BAG; Collector, SURGICAL MASK Dressing, wound, hydrophilic Skin and Wound Cleanser Enema bag, Enema kit, Enema Bag Set w/soaps; ENEMA BUCKET 1500ML W/SOAP; ENEMA SET SHOE AND SHOE COVER, CONDUCTIVE CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE CHAIR, WITH CASTERS Mattress, air flotation, alternating pressure CANE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Isolation gown, Protective gown, exam gown. ,Non-surgical gown DEPRESSOR, TONGUE, NON-SURGICAL apparatus, suction, single patient use, portable, nonpowered infusor, pressure, for i.v. bags - PRESSURE INFUSOR FOR AN I.V. BAG Safety lancet, personal protection kit CATHETER, NASAL, OXYGEN IPS AND PADS, CANE, CRUTCH AND WALKER tubing, noninvasive solvent, adhesive tape - Adhesive Remover Pad NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) disinfectant, medical devices - alcohol wipe SPECULUM, NON-ILLUMINATED Endotracheal Tube Gluco-Monitoring System MASK, OXYGEN, NON-REBREATHING SUCTION CATHETER Light, surgical, accessories, LIGHT HANDLE COVER COVER, MATTRESS (MEDICAL PURPOSES) Electrode, electrocardiograph drape, adhesive, aerosol - Disposable Surgical Drape Set, administration, intravascular I.V. Administration Set Safety lancet Wheelchair, mechanical Suture removal kit closure, wound, adhesive - Wound plaster BAG, RESERVOIR Pediatric Urine bag Paste-on,PASTE-ON FOR INCONTINENCE, Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder dispenser, solid medication - pill dispenser, pill box AIRWAY, NASOPHARYNGEAL Safety Sliding Blood Collection Set, Safety Butterfly Blood Collection Set, Sliding Blood Collection Set ACCESSORY, SURGICAL APPAREL Anesthesia breathing circuit kit (adult & pediatric) MARKER, SKIN Sharps Container shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - Protective Goggles; Gelling Fiber Wound Dressing catheter, ventricular, general & plastic surgery - Introduction/Drainage Catheter & Accessories URINAL BOTTLE, URINAL, BANDAGE, CAST, POP bandage, Casting bandage, Casting splint, Cast Paddings; Casting Tapes; Plaster Bandage; Stockinette SURGICAL GOWN CHAIR AND TABLE, MEDICAL IV Catheter, intravascular, therapeutic, short-term less than 30 days Continuous Measurement Thermometer bag, urine collection, leg, for external use, MASK, GAS, ANESTHETIC APPLICATOR, ABSORBENT TIPPED, STERILE; Specimen Collection Swab sterile absorber, saliva, paper - Denal Apron; Dental bibs, Patient Bibs device, urine flow rate measuring, non-electrical, disposable - device, urine flow rate measuring non-electrical, disposable - Urinemeters Boot Cover; Disposable Slipper; Shoe Cover; Sleeve Cover Massage Slippers; socks Strip, adhesive, closure, skin, Suture strip, WOUND CLOSURE STRIPS hydrocolloid foam dressing; nonwoven wound dressing; silicone dressing; silicone foam dressing; s super absorbency dressing; transparent island dressing dressing, wound, occlusive - foam dressing; Freevent Dressing SoftFoam; Heel foam dressing; hydrocolloid dressing; TOURNIQUET, NONPNEUMATIC Lancet first aid kit with drug PACK, HOT OR COLD, DISPOSABLE Gown, examination, exma gown, paper exam gown Gauze/sponge, internal, x-ray detectable, OR towel GARMENT, PROTECTIVE, FOR INCONTINENCE ORTHOSIS, LUMBAR System, measurement, blood-pressure, non-invasive respirator, surgical - N95 Surgical Respirator GOWN, SURGICAL BEDPAN,Commode ,Commode liner Blood Glucose Monitoring System General surgery tray Tracheostomy and nasal suctioning kit restraint, protective - ARM RESTRAINT STRAPS Speculum, vaginal, nonmetal system, blood collection, vacuum-assisted, manual - Blood Collection Needle Holder Sterilization Wrap, Autoclave Wrap ADHESIVE TAPE, BANDAGE, Skin Closure Strips Lubricant Jelly, splint, extremity, non-inflatable, external, non-sterile - Medical splints; ROLL SPLINT APRON, PROTECTIVE gauze sponge; Gauze Swabs 100% Cotton; Non woven towel; Non-woven Cleaning Towel; Orthopaedic Bandage; Lap sponge Abdominal Pad; Absorbent Cotton Wool; Absorbent Gauze Roll 100% cotton; Burn Pad; Conforming bandages; Cotton Ball; Dental Roll 100% cotton; Dressing Pack for Heavy Drainage; Dressing Pad Combined Absorbent; Dry Wipes; Gauze Roll; STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES) TUBE, ASPIRATING, FLEXIBLE, CONNECTING BRUSH, SCRUB, OPERATING-ROOM Wrap, sterilization, Autoclave wrap

Establishment Types

Export Device to the United States But Perform No Other Operation on Device