Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017210488

FEI Number

3017210488

Entity Name

VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.

City/State/Country

IZMIR, TR

Establishment Address

FATIH MAH. 1191 SK. 26/2 A BLOK, GAZIEMIR, IZMIR 35410, TR

Establishment Type(s)

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

Owner / Operator

VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. (Owner Number: 10076888)

Owner / Operator Contact Address

FATIH MAH. 1191 SK. 26/2 A BLOK, GAZIEMIR, IZMIR, TR-35 35410, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210423

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-01-24
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2026-02-06
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2026-02-06
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-02-06
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2026-02-06
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2021-10-19
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2025-12-15
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2021-10-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-10-19
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2025-08-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2021-05-31
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-01-03
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2026-01-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-07-09
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2025-07-09
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2021-10-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-10-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-11-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-05-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-01-23
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2021-09-15
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-09-15
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-09-15
KFK	Saw, Pneumatically Powered	General, Plastic Surgery	Class 1	878.4820	2021-09-15
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2021-09-15
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2021-09-15
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2021-09-15
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2024-01-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-11-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-02-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-02-26
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-04-13
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2024-06-28
NYU	Catheter, Hemodialysis, Implanted, Coated	Gastroenterology, Urology	Class 2	876.5540	2024-06-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-05-31
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2022-10-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-19
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-04-13
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2025-07-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-08-02
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-07-27
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-05-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-07-27
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-08-24
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2022-08-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-06-18
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-01-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-07-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-02-03
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-06-06
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-06-06
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2022-06-06
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2023-04-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-08-01
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-12-19
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2021-09-01
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2020-12-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-12-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-12-02
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2021-09-17
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2023-04-03
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2022-07-22
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2021-11-12
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2025-11-20
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-05-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-08-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-12-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-08-10
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2020-12-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-07-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-11-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-19
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-08-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-12-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-09-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-04-13
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-06-28
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2026-01-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-05-18
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2021-08-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-01-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-18
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-09-16
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2023-09-07
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2023-09-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-09-07
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2020-08-10
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2020-10-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-09-08
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-04-27
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2022-08-09
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-02-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-03-01
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2026-04-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-02-28
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2026-05-18
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-11-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-05-18
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-04-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-12-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-08-04
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2024-06-28
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2026-04-24
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2022-04-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-12-22
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-01-03
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-01-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-10-21
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-05-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-03-31
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-08-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-08-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-03-13
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-04-27
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2022-04-27
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-07-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-07-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-08-27
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2021-10-07
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2025-03-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-12-22
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-12-22
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2022-06-06
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-12-29
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-08-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-19
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2026-01-26
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2021-08-10
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-12-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-12-02
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-06-03
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2025-06-03
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-09-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2022-09-02
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-05-18

Official Correspondent

ANIL ERTEKIN

US Agent Details

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

Related Public Records

Same Entity

VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017210488. Last updated year: 2026. Please use registration number 3017210488 when referencing this establishment in official correspondence.