FDA Registration
Active
🇩🇪 Germany
SUBAN Instruments Germany GmbH
Reg #: 8010665
·
FEI: 1000405819
·
Expires 2026
Products
94
Proprietary Names
4
Establishment Types
2
Classifications
94
Registration Details
- Registration Name
- SUBAN Instruments Germany GmbH
- Registration Number
- 8010665
- FEI Number
- 1000405819
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 51 DORNIERSTRASSE
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- SUBAN Instruments Germany GmbH
- Operator Number
- 8010665
- Address
- DORNIERSTRASSE 51, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
- Correspondent
- Zoltan Honvari
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2012-06-21 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2013-01-31 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 1992-10-17 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2014-07-30 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-02-12 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2013-07-08 |
| Tenaculum, Uterine | HDC | Class 2 | Obstetrics/Gynecology | No | 2012-07-17 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-03-23 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2019-02-14 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2014-07-26 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-01-31 |
| Clip, Scalp | HBO | Class 2 | Neurology | No | 2013-02-15 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2013-03-16 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2014-04-23 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1985-06-18 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2014-07-26 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-03-16 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-31 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2014-04-25 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1999-12-17 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-02-11 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2015-11-19 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2012-01-26 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2012-06-19 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2015-06-18 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2013-12-05 |
| Discriminator, Two-Point | GWI | Class 1 | Neurology | No | 2013-07-24 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2019-06-06 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 1999-12-27 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2017-11-14 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2014-07-26 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 1999-12-27 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2020-02-11 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 1992-10-17 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2014-07-30 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 1999-12-27 |
| Device, Locking, For Intestinal Clamp | FFR | Class 1 | Gastroenterology, Urology | No | 2018-12-20 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-03-16 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1999-12-17 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2013-01-31 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-02-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-02-01 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2005-10-12 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 1992-10-21 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2014-07-30 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2013-01-31 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2015-02-09 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2013-03-16 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 1999-12-27 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 1999-12-27 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2014-07-30 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1999-12-27 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2014-07-30 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-03-16 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2013-03-16 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2013-01-31 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2014-07-17 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1983-08-29 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2019-10-10 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2013-07-08 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1999-12-27 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2013-03-16 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2014-07-30 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2005-10-12 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2018-09-06 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 1999-12-27 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2013-01-31 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2017-12-07 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2013-01-31 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2017-05-03 |
| Dynamometer, Nonpowered | HRW | Class 1 | Orthopedic | No | 2013-02-01 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2020-09-03 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2019-04-23 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 1985-06-18 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-01-31 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2016-09-16 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2005-10-12 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2014-09-23 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2021-04-27 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2017-03-13 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2005-10-12 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2013-02-11 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-03-16 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2013-03-16 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-03-16 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2019-09-16 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1999-12-27 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 1999-12-27 |
Proprietary Names
90-6210-02
90-6130
WL 01-0434
RL-251-062
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device