FDA Registration
Active
🇩🇪 Germany
GIMMI GMBH
Reg #: 9612074
·
FEI: 3002807072
·
Expires 2026
Products
106
Proprietary Names
8
Establishment Types
2
Classifications
106
Registration Details
- Registration Name
- GIMMI GMBH
- Registration Number
- 9612074
- FEI Number
- 3002807072
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CARL-ZEISS-STRASSE 6
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K981919
Owner / Operator
- Firm Name
- GIMMI GMBH
- Operator Number
- 8010570
- Address
- CARL-ZEISS-STRASSE 6, --
- City
- TUTTLINGEN
- State
- DE-NOTA
- Postal Code
- D-78532
- Country
- DE
- Correspondent
- Anita Rudischhauser
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 |
|---|---|---|---|---|---|
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2025-03-14 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 1987-11-11 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 1999-08-10 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2016-05-17 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2015-11-19 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 1986-05-06 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 1990-04-19 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1986-05-06 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 1986-05-20 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1990-04-19 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-07-17 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 1990-12-27 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1986-09-29 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1987-02-18 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1985-03-21 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2016-05-17 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 1987-03-02 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2024-07-17 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2024-07-17 |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
| Tenaculum, Uterine | HDC | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
| Screw, Fibroid, Gynecological | HHO | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 1987-03-02 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1987-05-05 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2009-12-10 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 1989-03-28 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1989-07-21 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 1987-06-30 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 1987-02-18 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1987-01-26 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 1987-09-11 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1987-03-11 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 1990-04-19 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2020-06-02 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2024-08-23 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2024-08-23 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-08-23 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2024-08-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 1987-02-18 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 1990-04-19 |
| Remover, Crown | EIS | Class 1 | Dental | No | 1989-07-21 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 1989-03-28 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2016-01-18 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 1992-08-12 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 1990-04-19 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1987-04-01 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2020-06-02 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1990-04-19 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2025-09-30 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 1987-03-11 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 1992-12-22 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 1989-03-28 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 1989-07-21 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2025-03-25 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1987-09-11 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2010-07-21 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2025-03-27 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2020-06-02 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1987-04-01 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2008-01-25 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 1987-03-11 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 1983-09-27 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1987-04-01 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1986-05-21 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 1987-02-18 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2016-05-17 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1987-03-02 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2025-11-25 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1992-06-15 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1985-03-21 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | Class 1 | Obstetrics/Gynecology | No | 2020-06-02 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2020-06-02 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 1991-01-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-06-02 |
| Probe, Rectal, Non-Powered | EXX | Class 1 | Gastroenterology, Urology | No | 1987-03-18 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2025-03-25 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1987-05-05 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 1998-11-25 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2016-09-21 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-03-14 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1987-02-18 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1991-01-28 |
| Amniotome | HGE | Class 1 | Obstetrics/Gynecology | No | 1992-12-22 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 1989-09-15 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2024-02-09 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 1987-04-01 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-06-02 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2024-08-30 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1989-07-21 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2015-11-19 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2025-03-14 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2024-01-12 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1985-03-21 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2016-05-17 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 1986-05-20 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2025-03-25 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2025-03-25 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2010-02-05 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2002-05-02 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2024-03-06 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 1999-08-10 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 1994-02-04 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 1991-01-28 |
| Pinwheel | GWY | Class 1 | Neurology | No | 1987-05-27 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 1987-04-01 |
Proprietary Names
GIMMI
Gimmi
Arthroscope
Gimmi nasal knifes
Tray
Endoscope
CLAMP, PENILE
STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device