FDA Registration
Active
🇭🇺 Hungary
SUBAN Instruments Hungary Co.
Reg #: 9680519
·
FEI: 3002631673
·
Expires 2026
Products
80
Proprietary Names
13
Establishment Types
1
Classifications
80
Registration Details
- Registration Name
- SUBAN Instruments Hungary Co.
- Registration Number
- 9680519
- FEI Number
- 3002631673
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 98. FUREDI street
- City
- DEBRECEN Hajdu-Bihar
- Country
- HU
Owner / Operator
- Firm Name
- SUBAN Instruments Hungary Co.
- Operator Number
- 9009574
- Address
- 98. FUREDI street, --
- City
- DEBRECEN
- State
- HU-NOTA
- Postal Code
- H - 4032
- Country
- HU
- Correspondent
- PETER - NAGY
US Agent
- Business Name
- Beate Weiss-Krull, Attorney at Law
- Contact Name
- Beate Weiss-Krull
- Address
- 1639 SE 58th Ave
- City
- Portland
- State
- OR
- ZIP
- 97215
- Country
- US
- [email protected]
- Phone
- 503 2340355
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-11-07 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2022-06-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-03-19 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1994-02-09 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1994-02-09 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2017-02-28 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 2021-06-22 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 2022-09-28 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1994-02-09 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2022-06-21 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2022-01-04 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2022-10-21 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2009-10-16 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2016-01-12 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-09-28 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2021-11-23 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2017-02-28 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2017-06-29 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2023-11-07 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2017-02-28 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2023-11-07 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2017-06-29 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2017-02-28 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1994-02-09 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2001-08-21 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2021-06-22 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1994-02-09 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2010-01-21 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2021-06-22 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2009-09-23 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2020-06-24 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2021-06-22 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2021-03-24 |
| Microscope, Operating, Non-Electric, Ophthalmic | HRB | Class 1 | General, Plastic Surgery | No | 2018-11-07 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2021-03-24 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2021-06-22 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2017-02-28 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2021-06-22 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2017-07-27 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2010-03-02 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2021-06-22 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2017-05-25 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2010-03-02 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1994-02-09 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2023-11-07 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2020-06-24 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2021-02-19 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2021-06-22 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2010-05-31 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2019-02-21 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2021-06-22 |
| Packer, Uterine | HDM | Class 1 | Obstetrics/Gynecology | No | 2010-03-02 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2022-06-21 |
| Hook, Fibroid, Gynecological | HDE | Class 1 | Obstetrics/Gynecology | No | 2010-03-04 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2022-09-28 |
| Speculum, Vaginal, Metal, Fiberoptic | HDG | Class 1 | Obstetrics/Gynecology | No | 2018-03-02 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2022-09-28 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1994-02-09 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2010-03-04 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2020-10-13 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2017-06-19 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2023-11-07 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2010-03-02 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2021-06-22 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2023-11-07 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2022-06-21 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2023-11-07 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2017-06-19 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2023-11-07 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2009-12-02 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2010-03-04 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2018-03-02 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2021-03-08 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2021-03-24 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 2022-06-21 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2017-06-29 |
Proprietary Names
OS925
GL3200
GL1902
GL1920
GL1910
GL1940
GL1930
BE465
SU6136
SU6129
SU6135
SU6130
SU6132
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)