BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    SANICURE BV

    Reg #: 3012494290 · FEI: 3012494290 · Expires 2026
    View on FDA
    Products
    407
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    407

    Registration Details

    Registration Name
    SANICURE BV
    Registration Number
    3012494290
    FEI Number
    3012494290
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Evert van de Beekstraat 104
    City
    SCHIPHOL Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K012991
    PMA Number
    BP010047

    Owner / Operator

    Firm Name
    Sanicure BV
    Operator Number
    10052769
    Address
    Evert van de Beekstraat 104
    City
    SCHIPHOL
    State
    Noord-Holland
    Postal Code
    11118 CL
    Country
    NL
    Correspondent
    Josef Hofer

    US Agent

    Business Name
    SSPT Inc
    Contact Name
    Celia Parnicky
    Address
    100 Se 3rd Ave Fl 10 Ste 1000
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33394
    Country
    US
    Email
    [email protected]
    Phone
    954 2610657

    Products

    Device Name Product Code
    Apparatus, Exhaust, Surgical FYD
    Material, Impression ELW
    Mouthpiece, Breathing BYP
    Spirometer, Diagnostic BZG
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Syringe, Piston FMF
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Transducer, Pressure, Catheter Tip DXO
    Esthesiometer GXB
    Ligator, Esophageal MND
    System, X-Ray, Extraoral Source, Digital MUH
    Cannula, Ophthalmic HMX
    Electrode, Electrocardiograph DRX
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Indicator, Physical/Chemical Sterilization Process JOJ
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Protector, Skin Pressure FMP
    Anoscope And Accessories FER
    Snare, Flexible FDI
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Set, Administration, Intravascular FPA
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Material, Tooth Shade, Resin EBF
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Applicator, Resin KXR
    Cement, Dental EMA
    Retractor GAD
    Respirator, Surgical MSH
    Audiometer EWO
    Blood Pressure Cuff DXQ
    Wrap, Sterilization FRG
    Pneumoperitoneum Needle FHO
    Syringe, Antistick MEG
    Continuous Measurement Thermometer FLL
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Exerciser, Finger, Powered JFA
    Connector, Ureteral Catheter EYK
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Needle, Hypodermic, Single Lumen FMI
    Solvent, Adhesive Tape KOX
    Post, Root Canal ELR
    Bandage, Liquid KMF
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Handpiece, Belt And/Or Gear Driven, Dental EFA
    Catheter, Irrigation GBX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Container, Specimen, Sterile FMH
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Silk GAP
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Dna Probe, Gardnerella Vaginalis MJM
    Device, Intravascular Catheter Securement KMK
    Cup, Prophylaxis EHK
    Tubes, Gastrointestinal (And Accessories) KNT
    Otoscope ERA
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    General Purpose Reagent PPM
    Oximeter DQA
    Tube, Collection, Capillary Blood GIO
    Electrode, Cutaneous GXY
    Sponge, Ophthalmic HOZ
    Tray, Surgical, Needle FSH
    Biopsy Needle FCG
    Neurosurgical Paddie HBA
    Arthroscope HRX
    Laparoscope, General & Plastic Surgery GCJ
    Accessories, Blood Circuit, Hemodialysis KOC
    Tube Tracheostomy And Tube Cuff JOH
    Insufflator, Laparoscopic HIF
    Gown, Surgical FYA
    Point, Silver, Endodontic EKL
    Drills, Burrs, Trephines & Accessories (Compound, Powered) HBF
    Spreader, Bladder Neck FHK
    Sleeve, Limb, Compressible JOW
    Apparatus, Electrosurgical HAM
    Instrument, Manual, Surgical, General Use MDM
    Dna-Reagents, Neisseria LSL
    Automated External Defibrillators (Non-Wearable) MKJ
    Surgeon'S Gloves KGO
    Clinical Sample Concentrator JJH
    Saw, Powered, And Accessories HAB
    Dilator, Esophageal KNQ
    Set, I.V. Fluid Transfer LHI
    Knife, Ophthalmic HNN
    Tourniquet, Pneumatic KCY
    Elevator, Surgical, General & Plastic Surgery GEG
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Clip, Implantable FZP
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Transducer, Ultrasonic, Diagnostic ITX
    Bronchoscope (Flexible Or Rigid) EOQ
    Gastroscope And Accessories, Flexible/Rigid FDS
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Instruments, Dental Hand DZN
    Sling, Arm ILI
    Tube, Aspirating, Flexible, Connecting BYY
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Dam, Rubber EIE
    Electrode, Needle, Diagnostic Electromyograph IKT
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Hearing Aid, Air-Conduction, Prescription ESD
    Splint, Hand, And Components ILH
    Mask, Surgical FXX
    Alloy, Amalgam EJJ
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    File, Pulp Canal, Endodontic EKS
    Instrument, Ent Manual Surgical LRC
    Cannula, Manipulator/Injector, Uterine LKF
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Support, Arm IOY
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Refractometer For Clinical Use JRE
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Test, Urine Leukocyte LJX
    Blood, Occult, Colorimetric, In Urine JIO
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Syringe, Cartridge EJI
    Tape And Bandage, Adhesive KGX
    Drape, Surgical, Antimicrobial KKX
    Accessories, Catheter KGZ
    Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test QSU
    Holder, Film, X-Ray EGZ
    Dressing, Compression MHW
    Tubing, Noninvasive GAZ
    Needle, Aspiration And Injection, Reusable GDM
    Non-Surgical Gown OEA
    Powder, Porcelain EIH
    Retainer, Matrix JEP
    Retractor, All Types EIG
    System, Irrigation, Urological LJH
    System, Thermal Regulating DWJ
    Gutta-Percha EKM
    Antigens, Cf (Including Cf Control), Influenza Virus A, B, C GNX
    Blade, Scalpel GES
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Products, Red-Cell Lysing Products GGK
    Applier, Surgical, Clip GDO
    Clip, Scalp HBO
    Cap, Surgical FYF
    Anesthesia Conduction Kit CAZ
    Unit, Operative Dental, Accessories NRD
    Instrument, Cutting, Operative EKD
    Sealant, Pit And Fissure, And Conditioner EBC
    Varnish, Cavity LBH
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Cord, Retraction MVL
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Latex Patient Examination Glove LYY
    Blade, Saw, Surgical, Cardiovascular DWH
    Stethoscope, Electronic DQD
    Scaler, Ultrasonic ELC
    Chair, Dental, Without Operative Unit NRU
    Gauge, Depth, Instrument, Dental EIL
    Catheter, Intravascular, Diagnostic DQO
    Coverslips, Microscope Slide KES
    Syringe, Restorative And Impression Material EID
    Resin, Root Canal Filling KIF
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    System, Transport, Aerobic JTW
    Accessories, Implant, Dental, Endosseous NDP
    Punch, Surgical LRY
    Bag, Urinary, Ileostomy EXH
    Orthosis, Limb Brace IQI
    Guide, Surgical, Instrument FZX
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Tray, Impression, Preformed EHY
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Curette, Periodontic EMS
    Evacuator, Gastro-Urology KQT
    Laparoscope, Gynecologic (And Accessories) HET
    Sterilizer, Chemical MLR
    Ophthalmoscope, Ac-Powered HLI
    Clamp, Umbilical HFW
    Recorder, Paper Chart DSF
    Staple, Removable (Skin) GDT
    Instrument, Biopsy KNW
    Marker, Ocular HMR
    Tube, Tympanostomy ETD
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Endoscopic Bite Block MNK
    Wax, Dental, Intraoral EGD
    Filter, Infusion Line FPB
    Helicobacter Pylori LYR
    Handpiece, Air-Powered, Root Canal Irrigation NYL
    Micro Pipette JRC
    Dressing, Wound, Occlusive NAD
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Speculum, Vaginal, Nonmetal HIB
    Catheter, Peritoneal GBW
    Culture Media, Non-Propagating Transport JSM
    Neurological Stereotaxic Instrument HAW
    Pliers, Surgical HTC
    Saline, Vascular Access Flush NGT
    Bur, Dental EJL
    Catheter, Nephrostomy LJE
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Stylet, Tracheal Tube BSR
    Forceps, General & Plastic Surgery GEN
    Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Rasp HTR
    Instrument, Diamond, Dental DZP
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Cotton, Roll EFN
    Formulations, Paraffin, All KEO
    Container, Sharps MMK
    Instrument, Ultrasonic Surgical LFL
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Spirometer, Therapeutic (Incentive) BWF
    Nipper, Malleus JYR
    Indicator, Biological Sterilization Process FRC
    Holder, Needle, Gastroenterologic FHQ
    Tube, Tracheostomy (W/Wo Connector) BTO
    System, Test, Infectious Mononucleosis KTN
    Dna Probe, Yeast MLA
    Amniotome HGE
    Airway, Oropharyngeal, Anesthesiology CAE
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Full-Montage Standard Electroencephalograph GWQ
    Device, Irrigation, Ocular Surgery KYG
    Anti Fog Solution And Accessories, Endoscopy OCT
    Enteral Specific Transition Connectors PIO
    Suction Control, Intracardiac, Cardiopulmonary Bypass DWD
    Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
    Plugger, Root Canal, Endodontic EKR
    Tube, Tracheal (W/Wo Connector) BTR
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Counter, Sponge, Surgical LWH
    Ligator, Hemorrhoidal FHN
    Trocar, Gastro-Urology FBQ
    Crown And Bridge, Temporary, Resin EBG
    Retractor, Self-Retaining FFO
    Automated Urinalysis System KQO
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Collector, Ostomy EXB
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Orthopedic Manual Surgical Instrument LXH
    Point, Abrasive EHL
    Evacuator, Oral Cavity EHZ
    Bronchoscope Accessory KTI
    C. Difficile Toxin Gene Amplification Assay OZN
    Forceps, Rubber Dam Clamp EJG
    Mask, Scavenging KHA
    Dressing, Wound, Drug FRO
    Razor, Surgical LWK
    Hemostat, Surgical EMD
    Tester, Pulp EAT
    Applier, Hemostatic Clip HBT
    Mirror, Mouth EAX
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Catheters, Suction, Tracheobronchial BSY
    Hysteroscope (And Accessories) HIH
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Forceps, Biopsy, Non-Electric FCL
    Visual, Pregnancy Hcg, Prescription Use JHI
    Bit, Drill HTW
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Agent, Tooth Bonding, Resin KLE
    Filter, Bacterial, Breathing-Circuit CAH
    Cannula, Surgical, General & Plastic Surgery GEA
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Electrode, Needle GXZ
    Exophthalmometer HLS
    Unit, Oral Irrigation EFS
    Dressing, Wound And Burn, Occlusive MGP
    Orthosis, Corrective Shoe KNP
    Topical Approximation System MZR
    Wheel, Polishing Agent EJQ
    Syringe, Irrigating (Non Dental) KYZ
    Pump, Infusion FRN
    Electrocardiograph DPS
    Lavage, Jet FQH
    Needle, Aspiration And Injection, Disposable GAA
    Scaler, Periodontic EMN
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Container, Liquid Medication, Graduated KYW
    Catheter, Percutaneous DQY
    Connector, Catheter GCD
    Mask, Gas, Anesthetic BSJ
    Catheter, Ventricular, General & Plastic Surgery GBS
    Bedding, Disposable, Medical KME
    Orthosis, Thoracic IPT
    Electrode, Electrosurgical JOS
    Tray, Surgical, Instrument FSM
    Device, Transfer, Patient, Manual FMR
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Lamp, Operating-Room FQP
    Scissors, General, Surgical LRW
    Locator, Root Apex LQY
    Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) LJC
    Connector, Airway (Extension) BZA
    System, Peritoneal, Automatic Delivery FKX
    Absorber, Saliva, Paper KHR
    Liner, Cavity, Calcium Hydroxide EJK
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Dispenser, Liquid Medication KYX
    Pusher, Band, Orthodontic ECS
    Syringe, Balloon Inflation, Exempt PTM
    Container, Specimen, Non-Sterile NNI
    Orthosis, Lumbar IQE
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Container, Specimen Mailer And Storage, Sterile KDT
    Bandage, Elastic FQM
    Gauze / Sponge,Nonresorbable For External Use NAB
    Die, Wire Bending, Ent, Sterile JXW
    Gag, Mouth KBN
    Saw, Electrically Powered DWI
    Mixer, Cement, For Clinical Use JDZ
    Hemostatic Metal Clip For The Gi Tract PKL
    Plaque Disclosing Agent QJC
    Stethoscope, Manual LDE
    X-Ray, Tomography, Computed, Dental OAS
    Orthosis, Cervical IQK
    Curette, Suction, Endometrial (And Accessories) HHK
    System, Abortion, Vacuum HHI
    Medical Glove, Specialty LZC
    Fentanyl And Other Opioid Protection Glove QDO
    Polymer Patient Examination Glove LZA
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Unit, Syringe, Air And/Or Water ECB
    Knife, Surgical EMF
    Blower, Powder, Ent KCL
    Stocking, Medical Support (For General Medical Purposes) FQL
    Pin, Fixation, Smooth HTY
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Warmer, Thermal, Infusion Fluid LGZ
    Tube, Gastro-Enterostomy KGC
    Device, Patient Transfer, Powered FRZ
    Accessory, Surgical Apparel LYU
    Table, Operating-Room, Pneumatic FWW
    Cover, Barrier, Protective MMP
    Curette, Surgical, General Use FZS
    Strip, Polishing Agent EHM
    Meter, Peak Flow, Spirometry BZH
    Joint, Ankle, External Brace ITW
    Forceps, Tooth Extractor, Surgical EMG
    Protector, Silicate EFX
    Bur, Ear, Nose And Throat EQJ
    Bandage, Liquid, Skin Protectant NEC
    Tube, Feeding FPD
    Bottle, Collection, Vacuum KDQ
    Splint, Nasal EPP
    Conserver, Oxygen NFB
    Drill, Dental, Intraoral DZA
    Scalpel, One-Piece GDX
    Pump, Nebulizer, Manual EPN
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus MZO
    Mask, Oxygen BYG
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Bulb, Inflation, For Endoscope FCY
    Forceps HTD
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
    Wound Dressing With Animal-Derived Material(S) KGN
    Crown, Preformed ELZ
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Cap, Device Disinfectant QBP
    Tube, Nasogastric BSS
    Pouch, Colostomy EZQ
    Media, Electroconductive GYB
    Hood, Surgical FXY
    Sealant, Microbial NZP
    Lead, Atomic Absorption DOF
    Accessories, Cleaning Brushes, For Endoscope MNL
    Dish, Tissue Culture KIZ
    Antisera, All Groups, Streptococcus Spp. GTZ
    Head, Surgical, Hammer GFB
    Accessories, Arthroscopic NBH
    Aspirator, Endometrial HFF
    Bandage, Cast ITG
    System, Hemoglobin, Automated GKR
    Cystotome HNY
    Support, Breathing Tube JAY
    Garment, Protective, For Incontinence EYQ
    Hand, External Limb Component, Powered IQZ
    Table, Examination, Medical, Powered LGX
    Instrument, Cast Removal, Ac-Powered LGH
    Bur, Surgical, General & Plastic Surgery GFF
    Applicator, Absorbent Tipped, Sterile KXG
    Laryngoscope, Rigid CCW
    Support, Patient Position CCX
    Elevator, Surgical, Dental EMJ
    Ophthalmoscope, Battery-Powered HLJ
    Absorber, Carbon-Dioxide BSF
    Strap, Head, Gas Mask BTK
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Instrument, Surgical, Disposable KDC
    Drape, Surgical, Exempt PUI
    Real Time Nucleic Acid Amplification System OOI
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Transilluminator, Battery-Powered HJN
    Dressing, Wound, Hydrophilic NAC

    Proprietary Names

    Suture, surgical, absorbable, polydioxanone Suture, surgical, nonabsorbable, expanded, polytetraflouroethylene MATERIAL, IMPRESSION Single use only blood lancet with an integral sharps injury prevention feature EBG - CROWN AND BRIDGE, TEMPORARY, RESIN EBF - Material, tooth shade, resin CLAVE Vial Access Spike Attest Indicator Vacuette Blood Collection Set 23 Gauge 3/4 Inch Needle Electrosurgical Container, sharps Mepilex Border Lite

    Establishment Types

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