BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    CBR ENTERPRISE LIMITED

    Reg #: 3013557562 · FEI: 3013557562 · Expires 2026
    View on FDA
    Products
    358
    Proprietary Names
    75
    Establishment Types
    1
    Classifications
    358

    Registration Details

    Registration Name
    CBR ENTERPRISE LIMITED
    Registration Number
    3013557562
    FEI Number
    3013557562
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    300 Des Voeux Road Central, Suite A, 9/F., Wah Kit Commercial Centre
    City
    Hong Kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K990236
    PMA Number
    P190007

    Owner / Operator

    Firm Name
    CBR Enterprise Limited
    Operator Number
    10054430
    Address
    300 Des Voeux Road Central, Suite A, 9/F., Wah Kit Commercial Centre
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    Hong Kong
    Country
    HK
    Correspondent
    Ephraim Grossman

    US Agent

    Business Name
    Gemstar Inc
    Contact Name
    Ephraim Grossman
    Address
    27 Robert Pitt Dr
    City
    Monsey
    State
    NY
    ZIP
    10952
    Country
    US
    Email
    [email protected]
    Phone
    845 4257676

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Catheter, Nephrostomy LJE
    Catheter, Suprapubic (And Accessories) KOB
    Introducer, Catheter DYB
    Guard, Instrument LXZ
    Set, Administration, Intravascular FPA
    Polymer Patient Examination Glove LZA
    Blade, Scalpel GES
    Mask, Surgical FXX
    Sleeve, Limb, Compressible JOW
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Latex Patient Examination Glove LYY
    Surgeon'S Gloves KGO
    Filter, Bacterial, Breathing-Circuit CAH
    Needle, Hypodermic, Single Lumen FMI
    Speculum, Vaginal, Nonmetal HIB
    Drape, Surgical, Antimicrobial KKX
    Electrocardiograph DPS
    Spirometer, Diagnostic BZG
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Post, Root Canal ELR
    Container, Sharps MMK
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Continuous Measurement Thermometer FLL
    Transducer, Pressure, Catheter Tip DXO
    Needle, Aspiration And Injection, Reusable GDM
    Tray, Surgical, Instrument FSM
    Dressing, Wound, Drug FRO
    Forceps, Biopsy, Electric KGE
    Stopcock, I.V. Set FMG
    Dressing, Wound, Hydrophilic NAC
    Set, Blood Transfusion BRZ
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Light, Surgical, Accessories FTA
    Device, Transfer, Patient, Manual FMR
    Pessary, Vaginal HHW
    Massager, Therapeutic, Manual LYG
    Stylet, Tracheal Tube BSR
    Device, Specimen Collection LIO
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Mixer, Cement, For Clinical Use JDZ
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Scissors, Ophthalmic HNF
    Stethoscope, Manual LDE
    Drills, Burrs, Trephines & Accessories (Compound, Powered) HBF
    System/Device, Pharmacy Compounding NEP
    Set, I.V. Fluid Transfer LHI
    Container, I.V. KPE
    Tubes, Vacuum Sample, With Anticoagulant GIM
    Automated External Defibrillators (Non-Wearable) MKJ
    Biopsy Needle FCG
    Instrument, Biopsy KNW
    Blood Pressure Cuff DXQ
    Oximeter DQA
    Cage, Knee ITM
    Laryngoscope, Rigid CCW
    Bag, Urine Collection, Leg, For External Use, Non-Sterile NNW
    Tubing, Pressure And Accessories BYX
    Powered Laser Surgical Instrument GEX
    Hemostatic Metal Clip For The Gi Tract PKL
    Punch, Surgical LRY
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Syringe, Antistick MEG
    Mask, Gas, Anesthetic BSJ
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Protector, Ostomy EXE
    Applicator, Ent Drug LRD
    Arthroscope HRX
    Bedding, Disposable, Medical KME
    Gown, Surgical FYA
    Forceps, Biopsy, Non-Electric FCL
    Respirator, Surgical MSH
    Tube, Tracheostomy (W/Wo Connector) BTO
    Device, Monitoring, Intracranial Pressure GWM
    Conserver, Oxygen NFB
    Tube, Tracheal (W/Wo Connector) BTR
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Syringe, Ent KCP
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Syringe, Irrigating (Non Dental) KYZ
    Orthosis, Sacroiliac, Soft IPW
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Shunt, Central Nervous System And Components JXG
    Orthosis, Lumbar IQE
    Indicator, Physical/Chemical Sterilization Process JOJ
    Tubes, Gastrointestinal (And Accessories) KNT
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Toothbrush, Powered JEQ
    Catheter, Urological KOD
    Lubricant, Patient KMJ
    Tubing, Noninvasive GAZ
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Curette, Suction, Endometrial (And Accessories) HHK
    System, Abortion, Vacuum HHI
    Splint, Hand, And Components ILH
    Electrode, Electrocardiograph DRX
    Bronchoscope (Flexible Or Rigid) EOQ
    Insufflator, Hysteroscopic HIG
    Clamp, Umbilical HFW
    Instrument, Ent Manual Surgical LRC
    Audiometer EWO
    Syringe, Piston FMF
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Needle, Aspiration And Injection, Disposable GAA
    Loop, Wire JYQ
    Sterilizer, Chemical MLR
    Computer, Diagnostic, Programmable DQK
    System, Irrigation, Urological LJH
    System, Thermal Regulating DWJ
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Knife, Ophthalmic HNN
    Airway, Oropharyngeal, Anesthesiology CAE
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Bag, Urine Collection, Newborn FOC
    Collector, Ostomy EXB
    System, Transport, Aerobic JTW
    Gauze / Sponge,Nonresorbable For External Use NAB
    Applier, Surgical, Clip GDO
    Pack, Hot Or Cold, Disposable IMD
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    System, Test, Automated Blood Grouping And Antibody KSZ
    Dilator, Esophageal KNQ
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Electrocautery, Gynecologic (And Accessories) HGI
    Hysteroscope (And Accessories) HIH
    Ophthalmoscope, Ac-Powered HLI
    Mask, Oxygen BYG
    Culture Media, Non-Propagating Transport JSM
    System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test NTW
    Oximeter, Ear DPZ
    Warmer, Thermal, Infusion Fluid LGZ
    Cannula, Manipulator/Injector, Uterine LKF
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Unit, Filter, Membrane JRL
    Container, Specimen, Sterile FMH
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Basin, Emesis FNY
    Hood, Surgical FXY
    Bag, Bile Collecting EXF
    Toothbrush, Manual EFW
    Instruments, Dental Hand DZN
    Curette, Uterine HCY
    Neurological Stereotaxic Instrument HAW
    Accessory, Surgical Apparel LYU
    Device, Intravascular Catheter Securement KMK
    Film, Radiographic IWZ
    Anti Fog Solution And Accessories, Endoscopy OCT
    Laparoscope, General & Plastic Surgery GCJ
    Catheter, Coude EZC
    Oximeter, Tissue Saturation MUD
    Tube Tracheostomy And Tube Cuff JOH
    Laryngoscope, Endoscope GCI
    Mouthpiece, Breathing BYP
    Wire, Guide, Catheter DQX
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Lavage, Jet FQH
    Ligator, Esophageal MND
    Cleaner, Ultrasonic, Medical Instrument FLG
    Bandage, Elastic FQM
    Cable, Electrode IKD
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Ventilator, Non-Continuous (Respirator) BZD
    Apparatus, Exhaust, Surgical FYD
    Instrument, Ultrasonic Surgical LFL
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Cover, Biopsy Forceps FFF
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Protector, Skin Pressure FMP
    Apparatus, Electrosurgical HAM
    Alloy, Amalgam EJJ
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Cannula, Surgical, General & Plastic Surgery GEA
    Cement, Stomal Appliance, Ostomy EZR
    Bottle, Collection, Vacuum KDQ
    Applicator, Absorbent Tipped, Sterile KXG
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD
    Accessories, Blood Circuit, Hemodialysis KOC
    Floss, Dental JES
    Insufflator, Laparoscopic HIF
    Catheter, Continuous Flush KRA
    Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
    Ear Wick KCN
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus MZO
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Pack, Hot Or Cold, Reusable IME
    Electrode, Needle, Diagnostic Electromyograph IKT
    Otoscope ERA
    Dilator, Vaginal HDX
    Cannula, Ophthalmic HMX
    Enteral Syringes With Enteral Specific Connectors PNR
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
    Blood/Plasma Collection Device For Dna Testing PJE
    Container, Liquid Medication, Graduated KYW
    Bandage, Liquid, Skin Protectant NEC
    Tourniquet, Nonpneumatic GAX
    Absorber, Carbon-Dioxide BSF
    Indicator, Biological Sterilization Process FRC
    Speculum, Vaginal, Metal HDF
    Bur, Ear, Nose And Throat EQJ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Computer, Oxygen-Uptake BZL
    Aid, Cardiopulmonary Resuscitation LIX
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Container, Specimen, Non-Sterile NNI
    Cover, Shoe, Operating-Room FXP
    Device, Percutaneous Retrieval MMX
    Medical Glove, Specialty LZC
    Blade, Saw, Surgical, Cardiovascular DWH
    Irrigator, Ostomy EXD
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Brush, Scrub, Operating-Room GEC
    Electrode, Cutaneous GXY
    Connector, Catheter GCD
    Instrument, Surgical, Disposable KDC
    Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection QPC
    Needle, Emergency Airway BWC
    Wrap, Sterilization FRG
    Electrode, Electrosurgical JOS
    Filter, Infusion Line FPB
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Bandage, Liquid KMF
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Lift, Patient, Non-Ac-Powered FSA
    Tampon, Menstrual, Unscented HEB
    Electrode, Needle GXZ
    Aid, Transfer IKX
    Spirometer, Therapeutic (Incentive) BWF
    Jelly, Lubricating, For Transurethral Surgical Instrument FHX
    Drape, Surgical, Exempt PUI
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Bag, Ice KYR
    Drill, Dental, Intraoral DZA
    Staple, Removable (Skin) GDT
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Orthopedic Manual Surgical Instrument LXH
    Bronchoscope Accessory KTI
    Nebulizer (Direct Patient Interface) CAF
    Dispenser, Liquid Medication KYX
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Non-Coring (Huber) Needle PTI
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Pump, Infusion FRN
    Recorder, Paper Chart DSF
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Bur, Surgical, General & Plastic Surgery GFF
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Paper, Articulation EFH
    Catheter, Irrigation GBX
    Catheter And Tip, Suction JOL
    Trocar DRC
    Cover, Cast KIA
    Connector, Airway (Extension) BZA
    Infusor, Pressure, For I.V. Bags KZD
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Tray, Surgical, Needle FSH
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Amniotome HGE
    Cystotome HNY
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Container, Specimen Mailer And Storage, Sterile KDT
    Bag, Urinary, Ileostomy EXH
    Depressor, Tongue, Non-Surgical FMA
    Dermatome GFD
    Ophthalmoscope, Battery-Powered HLJ
    Drills, Burrs, Trephines & Accessories (Manual) HBG
    Chair, Dental, Without Operative Unit NRU
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    Anoscope And Accessories FER
    Fiber, Medical, Absorbent FRL
    Vinyl Patient Examination Glove LYZ
    Bandage, Cast ITG
    Mouthpiece, Saliva Ejector DYN
    Catheter, Retention Type, Balloon EZL
    Neurosurgical Paddie HBA
    Tape And Bandage, Adhesive KGX
    Exophthalmometer HLS
    Catheter, Percutaneous DQY
    Catheter, Urethral GBM
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bag, Urine Collecting, Ureterostomy EXG
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Absorbent, Carbon-Dioxide CBL
    Dislodger, Stone, Biliary LQR
    Curette, Ear JYG
    Scissors, General, Surgical LRW
    Dilator, Urethral KOE
    Dilator, Catheter, Ureteral EZN
    Anesthesia Conduction Kit CAZ
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Dressing, Wound, Occlusive NAD
    Non-Surgical Gown OEA
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Tube, Tympanostomy ETD
    Collector, Urine, Powered, Non Indwelling Catheter NZU
    Marker, Skin FZZ
    Shoe, Cast IPG
    Drape, Urological, Disposable EYY
    Stand, Instrument, Ac-Powered, Ophthalmic HMF
    Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
    Catheter, Peritoneal GBW
    Stand, Instrument, Ophthalmic, Battery Powered NOI
    Elevator, Surgical, Dental EMJ
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Hemodialysis, Implanted MSD
    Dressing, Compression MHW
    Forceps, Ent KAE
    Full-Montage Standard Electroencephalograph GWQ
    Curette, Surgical, General Use FZS
    Fork, Tuning GWX
    Fentanyl And Other Opioid Protection Glove QDO
    Pill Crusher/Cutter OHY
    Strip, Temperature, Forehead, Liquid Crystal KPD
    Scalpel, One-Piece GDX
    Catheters, Suction, Tracheobronchial BSY
    Hook, Surgical, General & Plastic Surgery GDG
    Container, Specimen Mailer And Storage, Temperature Controlled, Sterile KDW
    Trocar, Gastro-Urology FBQ
    Clip, Implantable FZP
    Tube, Aspirating, Flexible, Connecting BYY
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Stethoscope, Electronic DQD
    Catheter, Intravascular, Diagnostic DQO
    Clip, Scalp HBO
    Hemostatic Device For Endoscopic Gastrointestinal Use QAU
    Dressing, Wound And Burn, Occlusive MGP
    Accessories, Cleaning Brushes, For Endoscope MNL
    Cannula, Nasal, Oxygen CAT
    Marker, Radiographic, Implantable NEU
    Handle, Scalpel GDZ
    System, Blood Culturing MDB
    Razor, Surgical LWK
    Slides, Microscope KEW
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Bottle, Collection And Trap, Breathing System (Uncalibrated) CBC

    Proprietary Names

    Tubes, vials, systems, serum separators, blood collection BAG, URINE COLLECTION, LEG, Needle Drape POST, ROOT CANAL FORCEPS, BIOPSY, ELECTRIC Device, specimen collection NEEDLE BC 21X1.25 ECL Stethoscope Electrosurgical, cutting & coagulation & accessories PROTECTOR, OSTOMY APPLICATOR FORCEPS, BIOPSY, NON-ELECTRIC Device, monitoring, intracranial pressure Shunt, central nervous system and components CURETTE, SUCTION, ENDOMETRIAL Insufflator, hysteroscopic Thermometer, electronic, clinical INSTRUMENT, ENT MANUAL SURGICAL Indicator, physical/chemical sterilization process COLLECTOR, OSTOMY HUMIDIFIER, RESPIRATORY GAS Syringe, piston HYSTEROSCOPE BLOOD TRANSFER AND LUER LOCK ACCES Oximeter, ear SOLUTION SET, CLEARLINK BURETROL CONTAINER, SPECIMEN, STERILE INSTRUMENTS, DENTAL HAND ENDOSCOPE Cleaner, ultrasonic, medical instrument VENTILATOR Instrument, ultrasonic surgical Tubes MBO-INDICATOR,CHEMICAL,TROPHON COVER,PROBE,CLEAN,TROPHON Catheter dc-defibrillator, Oximeter CONTAINER, LIQUID MEDICATION, GRADUATED Bandage, liquid, skin protectant STOPCOCK MANIFOLD 3 GANG LARGE BORE SPECULUM Polymer patient examination glove Irrigator, ostomy negative pressure wound therapy Powered suction pump PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Set, administration, intravascular Tube tracheostomy and tube cuff Tampon, menstrual, unscented DRILL, DENTAL, INTRAORAL intravascular SPIROMETER, MONITORING COVER, CAST CONNECTOR, AIRWAY Syringe FUSION OMNI-TOME Exophthalmometer Electrosurgical BAG, URINE COLLECTING CURETTE, EAR 3ml Syringe W/Dtchbl Needle 21G x 1 1/2" SET, TUBING AND SUPPORT, VENTILATOR Collector, urine SHOE, CAST CONNECTOR SLEEVE, LIMB, COMPRESSIBLE Tubes, gastrointestinal HOOK, SURGICAL, GENERAL & PLASTIC SURGERY Electrode, needle DRESSING, WOUND 4"X5" MEPILEX TRANSFER AG (5/BX Mask, surgical CLEANING BRUSHES, FOR ENDOSCOPE HYSTEROSCOPE ( Tubes, Blood Collection

    Establishment Types

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