FDA Registration
Active
🇹🇷 Türkiye
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.
Reg #: 3017210488
·
FEI: 3017210488
·
Expires 2026
Products
67
Proprietary Names
0
Establishment Types
1
Classifications
67
Registration Details
- Registration Name
- VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.
- Registration Number
- 3017210488
- FEI Number
- 3017210488
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FATIH MAH. 1191 SK. 26/2 A BLOK, GAZIEMIR
- City
- IZMIR
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K200818
- PMA Number
- P110010
Owner / Operator
- Firm Name
- VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.
- Operator Number
- 10076888
- Address
- FATIH MAH. 1191 SK. 26/2 A BLOK, GAZIEMIR
- City
- IZMIR
- State
- TR-35
- Postal Code
- 35410
- Country
- TR
- Correspondent
- ANIL ERTEKIN
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 protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2024-01-24 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2026-02-06 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2026-02-06 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-02-06 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2026-02-06 |
| Laryngoscope, Endoscope | GCI | Class 2 | Gastroenterology, Urology | No | 2021-10-19 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2025-12-15 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2021-10-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-10-19 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2025-08-08 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-01-03 |
| Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | ODD | Class 2 | Gastroenterology, Urology | No | 2026-01-26 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-07-09 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2025-07-09 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2021-10-05 |
| Saw, Pneumatically Powered | KFK | Class 1 | General, Plastic Surgery | No | 2021-09-15 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2021-09-15 |
| Motor, Surgical Instrument, Pneumatic Powered | GET | Class 1 | General, Plastic Surgery | No | 2024-01-03 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-02-28 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2024-02-26 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2024-02-26 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2024-06-28 |
| Catheter, Hemodialysis, Implanted, Coated | NYU | Class 2 | Gastroenterology, Urology | No | 2024-06-28 |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | Class 2 | General, Plastic Surgery | No | 2022-10-19 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2022-04-13 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2025-07-10 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-08-02 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2022-07-27 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2022-08-24 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2024-01-15 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2022-06-06 |
| Duodenoscope And Accessories, Flexible/Rigid | FDT | Class 2 | Gastroenterology, Urology | No | 2022-06-06 |
| Dilator, Esophageal | KNQ | Class 2 | Gastroenterology, Urology | No | 2022-06-06 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2023-04-03 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-12-19 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2021-09-01 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2020-12-22 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2024-12-02 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2024-12-02 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2021-09-17 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2021-11-12 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2025-11-20 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2020-12-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-07-10 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2024-06-28 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2026-01-26 |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2021-08-10 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2023-09-07 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2023-09-07 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-09-07 |
| Endoscopic Tissue Approximation Device | OCW | Class 2 | Gastroenterology, Urology | No | 2020-08-10 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2024-12-26 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2026-04-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-05-18 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2020-12-22 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2026-04-24 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2024-01-03 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2020-12-22 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2022-06-06 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2022-08-19 |
| Stylet For Catheter, Gastro-Urology | EZB | Class 1 | Gastroenterology, Urology | No | 2026-01-26 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2025-12-17 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-08-01 |
| Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | OXJ | Class 2 | General, Plastic Surgery | No | 2023-04-03 |
| Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | KDW | Class 1 | Pathology | No | 2024-01-31 |
| Apparatus, Suction, Patient Care | DWM | Class 2 | Cardiovascular | No | 2026-01-22 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2022-10-19 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device