BEUDAMED
    FDA Registration Active 🇸🇰 Slovakia

    MDTGLOBAL, A.S.

    Reg #: 3024021261 · FEI: 3024021261 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    97
    Establishment Types
    1
    Classifications
    50

    Registration Details

    Registration Name
    MDTGLOBAL, A.S.
    Registration Number
    3024021261
    FEI Number
    3024021261
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lomonosovova 2
    City
    Bratislava Bratislavsky
    Country
    SK

    Regulatory Submissions

    510(k) Number
    K041810
    PMA Number
    P010013

    Owner / Operator

    Firm Name
    MDTGlobal, a.s.
    Operator Number
    10085911
    Address
    Lomonosovova 2
    City
    Bratislava
    State
    Bratislavsky
    Postal Code
    811 09
    Country
    SK
    Correspondent
    Richard Cunderlik

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Resectoscope FJL
    Electrode, Electrosurgical, Active, Urological FAS
    Staple, Removable (Skin) GDT
    Laparoscope, Gynecologic (And Accessories) HET
    Laparoscope And Accessories, Gynecologic, Reprocessed NMH
    Laparoscope, General & Plastic Surgery GCJ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Staple, Implantable GDW
    Stapler, Surgical GAG
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Screw, Fixation, Bone HWC
    Applier, Surgical, Clip GDO
    Clip, Implantable FZP
    Accessories, Cleaning, For Endoscope FEB
    Hysteroscope (And Accessories) HIH
    Gastroscope And Accessories, Flexible/Rigid FDS
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Forceps, Biopsy, Electric KGE
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Mesh, Surgical, Polymeric FTL
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Telescope, Rigid, Endoscopic FBP
    Urethroscope FGC
    Endoscope, Neurological GWG
    Confocal Optical Imaging OWN
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Bronchoscope (Flexible Or Rigid) EOQ
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Device, Thermal Ablation, Endometrial MNB
    Accessories, Arthroscopic NBH
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Lithotriptor, Ultrasonic FEO
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Insufflator, Endoscopic Vessel Harvesting OSV
    Insufflator, Laparoscopic HIF
    Single-Use Reprocessed Ultrasonic Surgical Instruments NLQ
    Instrument, Ultrasonic Surgical LFL
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Staple, Fixation, Bone JDR
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Resectoscope, Working Element FDC
    Tube, Tympanostomy ETD
    Colonoscope And Accessories, Flexible/Rigid FDF
    Knife, Myringotomy JYP
    Arthroscope HRX
    Accessories, Cleaning Brushes, For Endoscope MNL

    Proprietary Names

    0279-351-100 WA22305D WA22302D WA22306D 8886803712 WA530005A WA4KL100 176630 173022 174317 173026 LF1944 LF1823 LF1923 LF1937 72202468 HF-resection Electrodes WA22355C, WA22351C,WA22503D EEA2835 MAJ1933 MAJ-1941 ASH4250-01 72201786 72201780 72201776 72201782 72201781 72201778 72201785 O0131 10-401FC 10-403FC GIF-TYPE XTQ160 ESG-410 VLOC Absorbable Wound Closure Device LF1837 LF1844 EGBPS-A WA00014A 134051 WA03300A LF2019 CLV-S400 CH-S400-XZ-EA SYM1510 GIA8038S,GIA8038L,GIA10038S 030458 EGIAUSTND EGIAUXL EGIAUSHORT GIA10038L VLOCL Absorbable Wound Closure Device ONB12STF PCO2H1 A4674A A4673A WA2T412A ABSTACK15 ABSTACK30X ABSTACK30 7230AA 7230AWA 031200-10 OTV-S400 OTV-S700 NS2013 0112760 0112770 0112780 0375-544-000 LF5637 0375-545-000 25-2800 SPL-SR E7507 UI400 HARH23,HARH36,HARH45 B12STF KD-655U 72205324 72205325 LPG1510 72200752 LF4418 UH801 72202595 EG145212 VLOCN Absorbable Wound Closure Device MAJ-1933 EG70130781 7211004 LS1020 72203378 TEM1208G B5STF ONB5STF BW-412T

    Establishment Types

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