FDA Registration
Active
🇩🇪 Germany
OTTO LEIBINGER GMBH
Reg #: 9614986
·
FEI: 3003424264
·
Expires 2026
Products
50
Proprietary Names
85
Establishment Types
2
Classifications
50
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Registration Details
- Registration Name
- OTTO LEIBINGER GMBH
- Registration Number
- 9614986
- FEI Number
- 3003424264
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 27 GRIESWEG
- City
- MUEHLHEIM Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- OTTO LEIBINGER GMBH
- Operator Number
- 9032125
- Address
- 27 GRIESWEG, --
- City
- MUHLHEIM
- State
- DE-NOTA
- Postal Code
- 78570
- Country
- DE
- Correspondent
- TINA - LEIBINGER-TOTH
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 |
|---|---|---|---|---|---|
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2013-02-05 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 1998-02-02 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2003-01-31 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2002-05-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-02-21 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2001-08-26 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2008-02-18 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2008-02-18 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-06-05 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2013-02-27 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2012-06-18 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2008-02-18 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2023-06-05 |
| Probe | HXB | Class 1 | Orthopedic | No | 2016-12-12 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2014-05-26 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2008-02-18 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2026-05-11 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2012-06-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2002-03-06 |
| File | HTP | Class 1 | Orthopedic | No | 2016-12-12 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2008-02-21 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2008-02-18 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2002-08-06 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2012-06-18 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 1998-02-02 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 1998-02-02 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2012-09-17 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2008-02-18 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2013-02-05 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2023-06-05 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2003-05-27 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2008-02-21 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2006-02-28 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2008-02-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-02-27 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2012-06-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2001-08-13 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2001-08-13 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2006-02-28 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2023-06-05 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2008-02-18 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-02-05 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2002-06-29 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2016-12-12 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2001-11-27 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2001-08-13 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2026-05-11 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2016-12-12 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2012-05-30 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2008-01-22 |
Proprietary Names
Miller Bone File
Bone File
BAND PUSHER
TAMP (MULTIPLE BRANDS)
Sharp Hook
PLASTIC SURGERY (MULTIPLE BRADS)
GSP24
Prichard
Periotome
Buser
Molt
Goldman Fox
Seldin
Raspatorie
Periostal Elevator
Gauze Packer
Bone Scraper
Scalpel Handle
Guide Drill
Periodontal Probe
Retractors all types
Minnesota Retractor
Mosquito Forceps
Ball Spike
Fragment Reduction Tool
Ergo Clip Wash Tray
Orthodontic Plier
Mathieu Needle Holder
Needle Holder, dental
Micro Needle Holder
GUIDES (MULTIPLE BRANDS)
Paralell Drilling Guide
Double Drill Sleeve
Castroveijo Measuring Gauge
Measuring Gauge
Bone Mill
Soft Corn Knife
Golf Stick Knife
Excavator
Tissue Pliers
Tooth Tweezers
Micro Tweezers
Suture Tweezers
Tooth Forceps
Root Splinter Forceps
Adson Tweezers
Dressing Forceps
MOSQUITO FORCEPS
DOUBLE SIDED BAND SETTE
Dollar Dissector
Filter for Suction Tube
Suction Tube with filter
Mirror Handle
Bone Curette
Curette McGlamry Bullneck
Curette
Ivory Rubber Dam Punch
Chisel
Root Elevator
BAll Spike
Beebee Crown Scissors
Oringer Retractor
RETRACTOR
Woodson Dural Separator
PERIODONTIC (MULTIPLE BRANDS)
Dental Scaler
Graft Impactor
Extracting Forceps
Root Forceps
Trephine
Curette Bullneck
Curette Excavator
Tunneling Knife
Tap Sleeve
BONE (MULTIPLE BRANDS)
Locke Elevator
Penfield Dissector
ELEVATOR
Luxator
Woodson Elevator
Dissector
Ligature Tucker
Micro Scissors
Denta Gum Scissors
Osteotome
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device