BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Synergy Sterilisation (M) Sdn Bhd

    Reg #: 3010220595 · FEI: 3010220595 · Expires 2026
    View on FDA
    Products
    114
    Proprietary Names
    73
    Establishment Types
    1
    Classifications
    114

    Registration Details

    Registration Name
    Synergy Sterilisation (M) Sdn Bhd
    Registration Number
    3010220595
    FEI Number
    3010220595
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Plot 203 Kuala Industrial Estate
    City
    Kuala Ketil Kedah
    Country
    MY

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10042227
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    Synergy Health
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 4687462

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL
    Nail, Fixation, Bone JDS
    Tube, Tracheal (W/Wo Connector) BTR
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Catheter, Coude EZC
    Orthopedic Manual Surgical Instrument LXH
    Catheter, Urethral GBM
    Catheter, Urological KOD
    Surgeon'S Gloves KGO
    Bronchoscope (Flexible Or Rigid) EOQ
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Electrode, Needle, Diagnostic Electromyograph IKT
    Laryngoscope, Rigid CCW
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Unit, Electrolysis, Battery-Powered, Ophthalmic HPY
    Forceps HTD
    Methyl Methacrylate For Cranioplasty GXP
    Separator, Automated, Blood Cell, Diagnostic GKT
    Catheter, Coronary, Atherectomy MCX
    Powered Laser Surgical Instrument GEX
    Instrument, Biopsy KNW
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Gastroscope And Accessories, Flexible/Rigid FDS
    Condom HIS
    Polymer Patient Examination Glove LZA
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    I.V. Start Kit LRS
    Rod, Fixation, Intramedullary And Accessories HSB
    Sheet, Burn FPY
    Apparatus, Electrosurgical HAM
    Tape And Bandage, Adhesive KGX
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Catheter, Continuous Flush KRA
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Stent, Superficial Femoral Artery NIP
    Forceps, Tube Introduction BWB
    System, Appendage Closure, Left Atrial NGV
    Clamp HXD
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Stent, Iliac NIO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Needle, Hypodermic, Single Lumen FMI
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Airway, Nasopharyngeal BTQ
    Retractor GAD
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Pin, Fixation, Threaded JDW
    Stylet, Tracheal Tube BSR
    Gauze / Sponge,Nonresorbable For External Use NAB
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Unit, Phacofragmentation HQC
    Medical Glove, Specialty LZC
    Container, Specimen, Sterile FMH
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Fentanyl And Other Opioid Protection Glove QDO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Dressing, Wound, Hydrophilic NAC
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Electrode, Needle GXZ
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer KRQ
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Scalpel, One-Piece GDX
    Curette HTF
    Tray, Surgical, Instrument FSM
    Aspiration Thrombectomy Catheter QEZ
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Screwdriver HXX
    Insufflator, Laparoscopic HIF
    Radiographic Protective Glove IWP
    Coronary Drug-Eluting Stent NIQ
    Scissors, General, Surgical LRW
    Syringe, Piston FMF
    Latex Patient Examination Glove LYY
    Cerclage, Fixation JDQ
    Forceps, General & Plastic Surgery GEN
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Needle, Suturing, Disposable GAB
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented MRA
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Toe, Constrained, Polymer KWH
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Supplies, Blood-Bank KSS
    Blade, Scalpel GES
    Implantable Transprostatic Tissue Retractor System PEW
    Instrument, Vitreous Aspiration And Cutting, Ac-Powered HQE
    Cannula, Trocar, Ophthalmic NGY
    Cannula, Ophthalmic HMX
    Photocoagulator And Accessories HQB
    System, Blood Collection, Vacuum-Assisted, Manual KST
    Airway, Oropharyngeal, Anesthesiology CAE
    Non-Coring (Huber) Needle PTI
    Pump, Infusion, Elastomeric MEB
    Apparatus, Autotransfusion CAC
    Tube Tracheostomy And Tube Cuff JOH
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Introducer, Catheter DYB
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF
    Device, General Purpose, Microbiology, Diagnostic LIB
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Laser, Ophthalmic HQF
    Arthroscope HRX
    Holder, Needle; Orthopedic HXK

    Proprietary Names

    Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN Noraker11562 (MS) - ARTHREX QUICKSET DELIVERING GUN; GRAFTYS QUICKSET DELIVERING GUN Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec Newclip11561 (MS) - Foot & Hand Motion screw spatula; Footmotion pin; HTO pin; Large screw pins Shoulder pins Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion Pins; Ambu10292 (KK) - Neuroline INOJECT Needle Electrode (744) Plexus10300 (KK) - GlideScope Spectrum Single Use System Molnlycke (VL,KK) - Biogel PI Micro surgical glove OsteoporeIntl (KK) - Osteopore PCL Scaffold Bone Void Filler Haemonetics (KK) - PCS WRP10943 (RW,KK) - Signature Latex Ortho Plexus10300 (KK) - EnCor EnCompassTM Breast Biopsy and Tissue Removal System Molnlycke (VL,KK) - Biogel PI Orthopro Ambu10292 (KK) - aScope Gastro Molnlycke (KK,VL) - Biogel PI surgical glove Boston (KK) - NC Emerge™ Monorail™ PTCA Dilatation Catheter Ambu10292 (KK) - Ambu aScope 5 Broncho HD 5/2.2 Sampler Set Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set Molnlycke (KK,VL1) - Biogel Indicator Underglove GoldenSeason (KK) - Dry sterile burn dressing Dexcom10877 (KK,BK) - Dexcom G7 Continuous Glucose Sensing System Molnlycke (KK,VL1) - Biogel NeoDerm; Biogel Skinsense N Ambu10292 (KK) - Ambu aScope 5 Broncho Sampler Set Ambu10292 (KK) - Ambu aScope 4 Broncho Large Ambu aScope 4 Broncho Regular Ambu aScope 4 Broncho Slim GoldenSeason (KK) - NAR COMPRESSED GAUZE; NAR S-ROLLED GAUZE; NAR Z-FOLD GAUZE Ambu10292 (KK) - Ambu® aScope™ 5 Uretero - Standard Deflection Ambu® aScope™ 5 Uretero - Reverse Deflection Molnlycke (VL,KK) - Biogel PI Micro Indicator Underglove Ambu10292 (KK) - aScope BronchoSampler 60 SC Klinika34754 (VL2) - Container, Specimen, Sterile Molnlycke (KK,VL) - Lyofoam Max FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive Molnlycke (KK,VL) - Lyofoam Dressings FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive Ambu10292 (KK) - Ambu® aScopeTM Duodeno 2 Ambu10292 (KK) - Neuroline Monopolar Needle Electrode (742) and 743) StrykerTrauma (RB) - Scalpel Ambu10292 (KK) - Ambu aScope 5 Broncho HD Molnlycke (KK,VL) - BIOGEL M Dexcom10877 (KK,BK) - Dexcom G7 15-Day Continuous Glucose Monitoring System Newclip11561 (MS) - Radius instrumentation set; Ulnar Instrumentation set Newclip11561 (MS) - ACTIV Ankle instrumentation set; ACTIV HTO instrumentation set; Activ instrumentation set Base; Acti DORC10527 (VL1) - Tray, Surgical, Instrument Newclip11561 (MS) - Stainless steel - Cover; HammerToe instrumentation set - Base; HammerToe instrumentation set Newclip11561 (MS) - Clavicle Distal instrumentation set; Elbow instrumentation set; Foot and Hand Motion Newclip11561 (MS) - Footmotion instrumentation set; Footmotion Plating System MTP instrumentation set; HammerToe Newclip11561 (MS) - Screws tray; Activ instrumentation set Top Alians Elbow Distal Humerus Y Plates instrumentation set Newclip11561 (MS) - HammerToe instrumentation set Stainless steel - Base; Humerus instrumentation set; Large screw Newclip11561 (MS) -Clavicle Plate screwdriver; Clavicle prehensor screwdriver countersink; Distal Radius Plate screwdriv Newclip11561 (MS) - ACTIV Ankle RemovalkitACTIV Ankle screwdriver; Alians Fragment Specific screwdriver; Alians screwdri Newclip11561 (MS) - Distal Radius removal kit; Elbow screwdriver; Foot & Hand Motion screwdriver; Footmotion screwdrive Newclip11561 (MS) - HTO hexagonal screwdriver; Large screw screwdriver; Newclip Radius screwdriver; Newclip Shoulder BSCI (KK,TL) - SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System BSCI (KK,TL) - SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System BSCI (KK,TL) - SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Molnlycke (VL,KK) - Biogel Skinsense BDPTE (RW) - BD Eclipse™ Injection Needle with BD Luer-Lok™ Syringe Ambu10292 (KK) - Ambu aScope 4 Broncho Regular Sampler Set 5/2.2 Ambu aScope 4 Broncho Large Sampler Set 5.8/2.8 Molnlycke (KK,VL) - Biogel Eclipse GoldenSeason (KK) - NAR Wound packing gauze Molnlycke (KK,VL1) - Biogel Sensor Glove; Biogel Super-Sensitive surgical glove Ambu10292 (KK) - Ambu aScope 5 Broncho 2.7/1.2 Ambu aScope 5 Broncho 4.2/2.2 Teleflex (KK) - RUSCH SILICONE FOLEY CATHETER Haemonetics (KK) - CELL SAVER Ambu10292 (KK) - Ambu® aScope™ Gastro Large Teleflex (KK) - RUSCH BRILLANT SILICONE FOLEY Dexcom10877 (KK, BK) - Stelo Glucose Biosensor System Molnlycke (KK,VL) - Biogel PI Pro-Fit surgical glove; Biogel PI Ultratouch G surgical glove; Biogel PI UltraTouch M Molnlycke (KK,VL) - Biogel PI UltraTouch surgical glove

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)