MDTGLOBAL, A.S.

FDA Device Registration & Listing · Bratislava Bratislavsky, SK · Registration 3024021261

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024021261
FEI Number
3024021261
Entity Name
MDTGLOBAL, A.S.
City/State/Country
Bratislava Bratislavsky, SK
Establishment Address
Lomonosovova 2, Bratislava Bratislavsky 811 09, SK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
MDTGlobal, a.s. (Owner Number: 10085911)
Owner / Operator Contact Address
Lomonosovova 2, Bratislava, SK-BL 811 09, SK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K171158
PMA Number
N/A

All Registered Proprietary Names

0279-351-100 WA22305D WA22302D WA22306D 8886803712 WA530005A WA4KL100 176630 173022 174317 173026 LF1944 LF1823 LF1923 LF1937 72202468 WA22302D WA22305D HF-resection Electrodes WA22306D WA22355C, WA22351C,WA22503D EEA2835 MAJ1933 MAJ-1941 ASH4250-01 72201786 72201780 72201776 72201782 72201781 72201778 72201785 176630 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 0375-544-000 0375-545-000 25-2800 SPL-SR E7507 UI400 HARH23,HARH36,HARH45 B12STF 72201776 72201782 72201781 25-2800 72201778 KD-655U

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-04-27
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2022-09-23
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2022-09-23
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2023-06-20
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2025-03-02
NMH Laparoscope And Accessories, Gynecologic, Reprocessed Obstetrics/Gynecology Class 2 884.1720 2025-03-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-03-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-02-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-07
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-01-10
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2022-09-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-23
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2023-05-29
GAG Stapler, Surgical General Hospital Class 2 878.4740 2023-05-29
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2026-03-17
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2026-03-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-01-10
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2026-02-11
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2026-02-11
FEB Accessories, Cleaning, For Endoscope Gastroenterology, Urology Class 2 876.1500 2023-10-06
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2022-09-23
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-07-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-08-01
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2022-09-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-07
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2025-06-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-01-30
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2024-08-20
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-03-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-07
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2025-03-02
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-03-02
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-08-01
OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2023-08-01
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2022-09-07
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2022-09-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-02-11
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-04-27
FBP Telescope, Rigid, Endoscopic Gastroenterology, Urology Class 2 876.1500 2024-12-05
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-12-05
FGC Urethroscope Gastroenterology, Urology Class 2 876.1500 2024-12-05
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-12-16
GWG Endoscope, Neurological Neurology Class 2 882.1480 2024-12-05
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2024-12-05
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2024-09-05
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-04-16
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2024-04-16
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2024-04-16
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2024-04-16
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-04-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-04-16
MNB Device, Thermal Ablation, Endometrial Unknown Class 3 N/A 2022-09-23
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-03-01
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2022-12-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-07
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2022-12-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-09-25
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2024-04-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-07
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope Gastroenterology, Urology Class 2 876.1500 2025-03-02
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2025-03-02
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2025-03-02
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2022-12-12
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2022-12-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-01-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-01-10
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2026-01-22

Official Correspondent

Richard Cunderlik

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

MDTGlobal, a.s.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0023-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Similar Registrations

Registration Number Establishment Name Location
3007353760 ENERGIST LIMITED Swansea, GB
3005064998 RDI INC. Mount Kisco, NY, US
3020623326 TRIWORKS GROUP S.R.L. Palata Campobasso, IT
3012616488 BRERA MEDICAL INCORPORATED Northborough, MA, US
3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024021261. Last updated year: 2026. Please use registration number 3024021261 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.