BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    PLATINUM FOCUS GROUP LTD.

    Reg #: 3030446844 · FEI: 3030446844 · Expires 2026
    View on FDA
    Products
    161
    Proprietary Names
    173
    Establishment Types
    3
    Classifications
    161

    Registration Details

    Registration Name
    PLATINUM FOCUS GROUP LTD.
    Registration Number
    3030446844
    FEI Number
    3030446844
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 5, 1000 North Circular Road
    City
    London London, City of
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K032840
    PMA Number
    P160022

    Owner / Operator

    Firm Name
    Platinum Focus Group Ltd.
    Operator Number
    10089900
    Address
    Unit 5, 1000 North Circular Road
    City
    London
    State
    London, City of
    Postal Code
    NW2 7JP
    Country
    GB

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Catheter, Cholangiography GBZ
    Dilator, Urethral KOE
    Syringe, Balloon Inflation MAV
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Catheter, Malecot FEW
    Catheter, Nephrostomy LJE
    Catheter, Suprapubic (And Accessories) KOB
    Tube Tracheostomy And Tube Cuff JOH
    Needle, Emergency Airway BWC
    Orthosis, Rib Fracture, Soft IPX
    Automated External Defibrillators (Non-Wearable) MKJ
    Bag, Bile Collecting EXF
    Drape, Surgical, Antimicrobial KKX
    Bandage, Liquid KMF
    Needle, Aspiration And Injection, Disposable GAA
    Cleaner, Denture, Mechanical JER
    Catheter, Intravascular, Diagnostic DQO
    Introducer, Catheter DYB
    Amniotome HGE
    Mouthpiece, Breathing BYP
    Dressing, Wound, Occlusive NAD
    Electrode, Electrocardiograph DRX
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Blood, Occult, Colorimetric, In Urine JIO
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Test, Urine Leukocyte LJX
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Enzymatic Method, Creatinine JFY
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Refractometer For Clinical Use JRE
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Bandage, Cast ITG
    Splint, Hand, And Components ILH
    Catheter For Crossing Total Occlusions PDU
    Wire, Guide, Catheter DQX
    Ventilator, Non-Continuous (Respirator) BZD
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Orthosis, Lumbo-Sacral IPY
    Elastomer, Silicone, For Scar Management MDA
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Connector, Airway (Extension) BZA
    Tubes, Gastrointestinal (And Accessories) KNT
    Cement, Stomal Appliance, Ostomy EZR
    Catheters, Suction, Tracheobronchial BSY
    Binder, Abdominal FSD
    Knife, Ophthalmic HNN
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Biopsy Needle FCG
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Nebulizer (Direct Patient Interface) CAF
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Cystotome HNY
    Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
    Cleaner, Ultrasonic, Medical Instrument FLG
    Restraint, Protective FMQ
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Ventilator, Continuous, Facility Use CBK
    Orthosis, Corrective Shoe KNP
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Orthosis, Limb Brace IQI
    Mask, Oxygen BYG
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Transducer, Gas Flow BXP
    Gown, Surgical FYA
    Catheter And Tip, Suction JOL
    Pack, Hot Or Cold, Water Circulating ILO
    Hemostatic Metal Clip For The Gi Tract PKL
    Container, Liquid Medication, Graduated KYW
    Container, Specimen, Non-Sterile NNI
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Trocar, Gastro-Urology FBQ
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Light, Surgical, Accessories FTA
    Wax, Bone MTJ
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Spirometer, Diagnostic BZG
    General Purpose Reagent PPM
    Introducer, Syringe Needle KZH
    Drape, Surgical, Exempt PUI
    Trocar DRC
    Arthroscope HRX
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Bandage, Elastic FQM
    Cable, Electrode IKD
    Giemsa Stain HYF
    Airway, Oropharyngeal, Anesthesiology CAE
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Protector, Skin Pressure FMP
    Cannula, Nasal, Oxygen CAT
    Laryngoscope, Rigid CCW
    Clamp, Umbilical HFW
    Helmet, Surgical FXZ
    Probe HXB
    Insoles, Medical KYS
    Scalpel, One-Piece GDX
    Joint, Knee, External Brace ITQ
    Joint, Hip, External Brace ITS
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Computer, Oxygen-Uptake BZL
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Curette, Suction, Endometrial (And Accessories) HHK
    Meter, Peak Flow, Spirometry BZH
    Electrocardiograph DPS
    Blood Pressure Cuff DXQ
    Absorber, Carbon-Dioxide BSF
    Instrument, Biopsy KNW
    Blade, Scalpel GES
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Splint, Abduction, Congenital Hip Dislocation IOZ
    Camera, Surgical And Accessories KQM
    Cage, Knee ITM
    Anoscope And Accessories FER
    Ligator, Hemorrhoidal FHN
    Absorbent, Carbon-Dioxide CBL
    Set, I.V. Fluid Transfer LHI
    Aid, Cardiopulmonary Resuscitation LIX
    Instrument, Ligature Passing And Knot Tying HCF
    Catheter, Irrigation GBX
    Hook, Ophthalmic HNQ
    Oximeter DQA
    Pad, Neonatal Eye FOK
    Dressing, Wound, Hydrophilic NAC
    Accessories, Blood Circuit, Hemodialysis KOC
    Connector, Catheter GCD
    Filter, Bacterial, Breathing-Circuit CAH
    Needle, Hypodermic, Single Lumen FMI
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Transducer, Pressure, Catheter Tip DXO
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Hematoxylin HYJ
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Osmometer For Clinical Use JJM
    Joint, Ankle, External Brace ITW
    Scale, Patient FRW
    Marker, Skin FZZ
    Bottle, Collection, Vacuum KDQ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Mixer, Cement, For Clinical Use JDZ
    Protector, Ostomy EXE
    Spirometer, Therapeutic (Incentive) BWF
    Collector, Ostomy EXB
    Orthosis, Lumbar IQE
    Cutter, Surgical FZT
    Adaptor, Ureteral Catheter EYI
    Endoscopic Cytology Brush FDX
    Cannula, Ophthalmic HMX
    Tape And Bandage, Adhesive KGX

    Proprietary Names

    MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET GASTROENTEROLOGY-UROLOGY BD Nexiva Single Port "Y" with one BD Q-Syte Luer Access System Circuit, breathing (w connector, adaptor, y piece) Precision Flow Heliox CATHETER, NEPHROSTOMY Tube tracheostomy and tube cuff Maternity Belt Large Automated external defibrillators (non-wearable) Catheter - Drainage (IR) Universal Gravity Bag Drape HIP Surgical KMF - Bandage, liquid BD Blunt Fill Needle 18G x 1" Y Connector Prismaflex Box of 50 Beacon tip catheter Drape, Surgical Introducer, catheter AmniHook Amniotic Membrane Perforator EXTENSION SET SPIRAL COILED POLYETHYLENE 1.5MM ID X 2.5MM OD X 400CM LUER LOCK Nexiva Single Port "Y" with one BD Q-Syte Luer Access System MOUTHPIECE, BREATHING Allevyn Sacrum Resting Electrodes Solid Gel Siemens Multistix 10SG Urinalysis Reagent Strips BANDAGE, CAST Procare Finger Splint Catheter for crossing total occlusions; Wire, guide, catheter Ventilator, non-continuous (respirator) Children’s BiliCal Disposable Calibration Tip ORTHOSIS, LUMBO-SACRAL Elastomer, silicone, for scar management Sutures Absorbable monoderm Connector 15mm Peel-Away Introducer Cement, stomal appliance, ostomy Closed Suction Catheter Trach Care 72 14 Fr. Tracheostomy BINDER, ABDOMINAL Cook Inflation Device Micro Knife Catheter - Drainage (IR) ultrathane PENCIL NEPTUNE SMOKE EVACCOATED 10/PK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. NEEDLE Stents, drains and dilators for the biliary ducts Nebulizer (direct patient interface) Bag, bile collecting Acrobat 2 Calibrated Tip Wire Guide Cystotome Irrigation AmnioTest (100 pack); AmnioTest (20 Pack); AmnioTest Colour Cards; Bulk dipped AmnioTest swabs DETERGENT, NEPTUNE ENZYMATIC Tubigrip Multi-Purpose Elasticated Tubular Support Bandage Set, tubing, blood, with and without anti-regurgitation valve CBK - Ventilator, continuous, facility use Lectro-Spiral Extension Tubing Dilation- Inflation devices/Syringes Minitrax Ankle Walker Medium Blue Whale Unistik 3 Extra - Single use only blood lancet with an integral sharps injury prevention feature Tru-Pull Lite Knee Brace Right Large ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE BYG - MASK, OXYGEN TRANSDUCER, GAS FLOW, ID Flow Sensor CATHETER AND TIP, SUCTION Knee Cryo/Cuff ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Hemostatic metal clip for the GI tract CONTAINER, LIQUID MEDICATION, GRADUATED Fusion Titan Dilation Balloon X10 BEAKER HDPE WHITE 5L Precision Reverse Cutting Black Nylon Monofilament Suture One-Part Percutaneous Entry Needle Drape, surgical FUSION QUATTRO  EXTRACTION BALLOON. EXTRACTION BALLOON Flexor, Check-Flo, Introducer Ansel Modification Trumpf Alc Plus Disposable Light Handle Integrated smoke evacuation pencil Bone Wax Suture Tubes, gastrointestinal ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY Eco BVF Filter Mouthpiece Oil Immersion Tube Low Viscosity INTRODUCER, SYRINGE NEEDLE THERMABASIN USE WITH INTRATEMP Arthroscopy Ablation Probe 4mm Crossblade Dual Edge Bandage, liquid Suture, nonabsorbable, synthetic, polypropylene MOLICARE PREMIUM ELASTIC molicare prem elastic slip HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) CABLE, ELECTRODE Disposable Patient Circuit High Flow Three Step Stain Solution B TRACER METRO DIRECT  WIRE GUIDE Laryngeal Mask Airway Silicone Cuff with Cuff Manometer - AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Cable/Connector patient monitoring Interface cable Tubes, vials, systems, serum separators, blood collection SILICONE HEEL CUPS ETCO2 Concentration Mask Adult CO2 Monitoring Line and Tube 2.1m CANNULA, NASAL, OXYGEN LARYNGOSCOPE, RIGID Needle Electrode Single Use Hex Hub Umbilical Cord Clamp Clipper PADS T7 COMFORT Unistik 3 Comfort Lancets Silicone Heel Cups Scalpel No. 11 Safety St. Orthopedic Universal Extremity Drapes Guidewire - Speciality (IR) straight fixed core Plantar Fasciitis Night Splint Medium Iso FORM TLSO Mini D-fend Water Trap Pipet Curet Endometrial Suction Curette Philips Diagnostic Resting Electrodes Solid Gel Wire, guide, catheter METER, PEAK FLOW, SPIROMETRY Cable/Connector Patient Monitoring blood pressure cuff Clamp, umbilical The Pyramid 1kg Pre-filled Disposable CO2 Absorber Lunderquist Extra-Stiff Wire Guide Bard Mission Disposable Core Biopsy Instrument; Bard Mission Disposable Core Biopsy Instrument Kit BLADE, SCALPEL Duette Multi-Band Mucosectomy Device - Unit, electrosurgical, endoscopic Sphincterotome Unistik 3 Normal - Single use only blood lancet with an integral sharps injury prevention feature Procare Finger Splint Curved & Padded Camera Stack Ancillary Sony Ink Rolls & Paper TUBE TRACHEOSTOMY AND TUBE CUFF CAGE Knee Vacutainer Luer-Lok Access Device - Tubes, vials, systems, serum separators, blood collection Anoscope and accessories Drager CLIC Absorber Spike Adapter Accessory Laparoscopic Suturing Suture PassOR Laparoscopic Port closure device Chest Drain Unit FUHRMAN PLEURAL/PNEUMOPERICARDIAL Drainage Set Tracheostomy Tube Neonatal Uncuffed Neonatal Flextend Plus Extra length V neck flange tracheostomy tube 3mm Balloon - Extraction Fusion w multiple sizing injection port above - Biliary Catheter Plastic Handle Instruments - Hook, ophthalmic Oximeter PAD, NEONATAL EYE Micropuncture Access Set - Introducer, catheter Cutimed Sorbion Sachet Drainage Bag Connector Connecting Tube Filta-Guard Breathing Filter 3M Cavilon No Sting Barrier Film Spray Bottle BD Vacutainer Eclipse Safety Blood Collection Needles BD Microtainer Contact-Activated Lancet DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION FGE - Stents, drains and dilators for the biliary ducts TRANSDUCER, PRESSURE, CATHETER TIP Nasal Jejunal Feeding Tube Burr Precision Round 6mm HEMATOXYLIN Analyzer BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL - Endoscopic grasping/cutting instrument, non-powered, exempt OSMOMETER FOR CLINICAL USE AirSport Ankle Brace Right Medium seca 212 Measuring Tape for Head Circumference of Babies & Toddlers Aspen Marker Skin Dual Fine Utl/Skin Multi-Chamber Polyp Trap Pro-Lab AmnioTest NSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Revolution Cement Mixing System with Femoral Breakaway Nozzle Protector, ostomy SPIROMETER, THERAPEUTIC (INCENTIVE) Collector, ostomy I-Gel O2 Resus Pack Drape Arthroscopy, Surgical CATHETER, NEPHROSTOMY KOB - CATHETER, SUPRAPUBIC DRILLS, BURRS, TREPHINES & ACCESSORIES Premium Panel Elastic Binder ADAPTOR, URETERAL CATHETER PATIENT SPIROMETRY SET Mission Disposable Core Biopsy Instrument Kit Endoscopic cytology brush Hydrodissecto Smith & Nephew Opsite Post-Op 6.5 x 5cm

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device