BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Integra Biotechnical, SA de CV

    Reg #: 3009746061 · FEI: 3009746061 · Expires 2026
    View on FDA
    Products
    77
    Proprietary Names
    164
    Establishment Types
    1
    Classifications
    77

    Registration Details

    Registration Name
    Integra Biotechnical, SA de CV
    Registration Number
    3009746061
    FEI Number
    3009746061
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Privada Los Pinos #17030 Interior 15, 16, 17, Colonia Ninos Heroes Este, C.P, Ave. Via Rapida Poniente #16835 Interior 3, Centro Ind. Los Pinos II, Colonia Ninos Heroes Este, C.P.
    City
    Tijuana Baja California
    Country
    MX

    Owner / Operator

    Firm Name
    Amphenol Critical Medical Technologies, LLC
    Operator Number
    9030406
    Address
    9586 Distribution Avenue, Suite F
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Lamont Rohde

    US Agent

    Business Name
    Amphenol Critical Medical Technologies, LLC
    Contact Name
    Lamont Rohde
    Address
    9586 Distribution Avenue, Suite F
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    602 7503539

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Catheter, Infusion JCY
    Introducer, Catheter DYB
    Low Electric Field Generator For Pancreatic Cancer Treatment SHC
    Catheter, Straight EZD
    System, Thermal Regulating DWJ
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Label Or Tag, Sterile LYV
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Curette, Surgical, General Use FZS
    Tubing, Fluid Delivery FPK
    Catheter, Conduction, Anesthetic BSO
    Arthroscope HRX
    Electrical Tumor Treatment Fields QGZ
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Device, Fixation, Tracheal Tube CBH
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Evacuator, Gastro-Urology KQT
    Resectoscope FJL
    Accessory, Surgical Apparel LYU
    Instrument, Manual, Surgical, General Use MDM
    Catheter Introducer Kit OFD
    Forceps, Biopsy, Gynecological HFB
    Tubes, Gastrointestinal (And Accessories) KNT
    Marker, Skin FZZ
    Stylet, Tracheal Tube BSR
    Device, Cystometric, Hydraulic FEN
    Pump, Infusion FRN
    Scalpel, One-Piece GDX
    Uroflowmeter EXY
    Device, Surgical, Cryogenic GXH
    Pump, Infusion, Pca MEA
    Bandage, Liquid, Skin Protectant NEC
    Meter, Peak Flow, Spirometry BZH
    Monitor, Breathing Frequency BZQ
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Catheter, Intravascular, Diagnostic DQO
    Needle, Aspiration And Injection, Disposable GAA
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Injector And Syringe, Angiographic DXT
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Kit, Surgical Instrument, Disposable KDD
    Filter, Bacterial, Breathing-Circuit CAH
    Bag, Bile Collecting EXF
    Syringe, Piston FMF
    Pump, Infusion, Ophthalmic MRH
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Container, Specimen, Sterile FMH
    Curette, Uterine HCY
    Blade, Scalpel GES
    Dna Specimen Collection, Saliva OYJ
    Slide Stainer, Automated KPA
    Tube, Tracheal (W/Wo Connector) BTR
    Station, Pipetting And Diluting, For Clinical Use JQW
    Hysteroscope (And Accessories) HIH
    Insufflator, Hysteroscopic HIG
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Needle, Hypodermic, Single Lumen FMI
    Handle, Scalpel GDZ
    Tourniquet, Nonpneumatic GAX
    Orthopedic Manual Surgical Instrument LXH
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Warmer, Thermal, Infusion Fluid LGZ
    Pressure Ulcer Management Tool QEF
    Powered Laser Surgical Instrument GEX
    Infusor, Pressure, For I.V. Bags KZD
    Device, Transfer, Patient, Manual FMR
    Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer SDA
    Syringe, Irrigating (Non Dental) KYZ
    Stimulator, Low Electric Field, Tumor Treatment NZK
    Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered PUL
    Container, I.V. KPE
    Instrument, Surgical, Disposable KDC
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Mmp-9 Test System PFQ
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    Miser Contrast Management 20-1615-10 BXPU636 R8704 RE7517 20-1620-12 R8772 20-1520-18L BXPU516 3104 20-1500-24 BXPU536 BXPU816 SA0300015 BXPU424 200795-001 ZTUBG-075 10-1550 BXPU524 200603-001 R8774 BXPU616 20-1500-18 BXPU624 20-1500-09 20-1615-10F 1025569 BXPU836 ZTUBG076 20-1520-18 200684-001 BXPU824 10-1550-001 010-062 Part Numbers BXPU416 20-1500-12 3901-1020 1019974 R8731 POWERWAND XL 4Fr 8cm Extended Dwell Catheter POWERWAND XL 5Fr 10cm Extended Dwell Catheter 5 Fr 10cm POWERWAND Safety Introducer with Extended Dwell Catheter 4 Fr 10cm POWERWAND Safety Introducer with Extended Dwell Catheter POWERWAND XL 5Fr 8cm Extended Dwell Catheter 5 Fr 8cm POWERWAND Safety Introducer with Extended Dwell Catheter 4 Fr 8cm POWERWAND Safety Introducer with Extended Dwell Catheter POWERWAND XL 4Fr 10cm Extended Dwell Catheter Vascular Pathways Introducer Perfic Cath (Adapta) MAXITHERM PowerLoc Safety Infusion Set Correct Medication Labeling System Ansell Sandel Medical Solutions LLC Medication Labels-Sandel Specimen Handling System Ventilator, Emergency, Powered (resuscitator) PowerLoc MAX Power Injectable Infusion Set SafeStep Huber Needle Set Fluid Administration Set Merit Medical Systems, Inc. FAS Soft K-Bride; Soft K-Rette DirectFlow Fenestrated Catheters (Ambit Tunnerler) FMS VUO Tubing assemblies NovoTTF 100L System HOPE NEBULIZER STABLTRACH Corinth MedTech, Inc. FACE-IT SHIELD CT Transfer and related subassemblies (Merit) FAS Lines (Merit) Blade Disarmer Z-Tray Specimen Bowl Z-Cord and Tube Holder Change-A-Blade Z-Suture Bag Z-Friction Drape Z-Universal Holder Z-Scope Holder Histologics SoftBiopsy Tissue Collection and Transport System EntraCare Time Out Marker Sandel Safety Marker LiftLoc Safety Infusion Set MiniLoc Safety Infusion Set Sandel Safety SCALPEL Miniloc Safety Infusion sets PowerLoc Max Safety Infusion Set Pacira Pharmaceuticals Inc. ambIT PreSet PCA Pump Aplicare Convenience Kits Aplicare Dressing Change Kit Creative Biotech Flow Meter CPAP Breathing Circuit and Mask CPAP Outset Medical, Inc. AMBIT Continuous Ambulatory Infusio Merit Disposal Depot Monojet Bone Marrow Biopsy Cardiopulmonary Bypass Blood Reserv ambIT PreSet Pump Fill Tube -720-000-0001 Tubing, Polyethylene J Tube Hook Tube MoBio Tube & Spin Filter Filter PowerLoc Safety Huber Merit Disposal Depot (BAG) MY8020-0006, MY8030-0006 & MY8060-0006 Part numbers: MY8003, MY8005, MY8010, MY8020, MY8030, MY8060, MY8003-0006, MY8005-0006, MY8010-0006, Texium Syringe Tube Sets GEL MATRIX The Wand Micro Access Safety Introd Ansell Sandel Specimen Bowl Specimen Container Soft Endo Cervical Curette Histologics Soft-ECC Los Alamos Retractable Knife Futura Safety Scalpel ambIT Uni-Flo Fenestrated Catheter SDNA-1000 Saliva Collection Device Ventana Medical Pouch subassembly SwiftGrip BioPointe Pipette Tips BioPointe Bulk Pipette Tips Huber Needle infusion set RPS Adeno Detector, Catalogs: RPS-AD, RPS-DE, FSC-AD, NIC-AD Autosafe Advantage Safety Huber Infusion Set Autosafe-Reflex Safety Huber Infusion Set Sandel Safety Scalpel Time Out Scalpel Handle T Ring Digit tourniquet, T Ring Toe Tourniquet Arthoscopic CAnnula (2.5 MM & 4.5 MM) Thermal Angel Blood/Fluid Warmer FMS DUO tubing assemblies CT Sets FAS MDD Iridex Corp. Pressure Infusor Bag (PIB) Tissue Catch with Suction Tubing Waste Management Accessory Waste Bag, 6L Fluid Management Accessory Summit Medical Ambulatory Infusion Pump AMBIT Push & Play Z-Slider Performa Catheters Optune Lua - Electrical tumor treatment fields for Non-Small Cell Lung Cancer Huber Plus POWERWAND Safety Introducer with an Extended Dwell Catheter, 3 Fr. Model WIN SHEILD Disposable electrodes (Part NOV 022/NOV 024) NOVOCURE NOVOTTF-100A SYSTEM Baker Intestinal Tube International Health Products Baker Jejunostomy Tube IHP Baker Jejunostomy Catheter IV Bag Scalpel disarmer InflammaDry

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)