FDA Registration
Active
🇩🇪 Germany
HGR INSTRUMENTE GMBH
Reg #: 8044098
·
FEI: 3004028763
·
Expires 2026
Products
119
Proprietary Names
3
Establishment Types
1
Classifications
119
Registration Details
- Registration Name
- HGR INSTRUMENTE GMBH
- Registration Number
- 8044098
- FEI Number
- 3004028763
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sattlerstrasse 35
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- HGR INSTRUMENTE GMBH
- Operator Number
- 9067456
- Address
- Sattlerstrasse 35, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
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 |
|---|---|---|---|---|---|
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 1999-12-20 |
| Graft, Vascular, Stainless Steel Tunneler | MZY | Class 2 | Cardiovascular | No | 2013-01-18 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-07-04 |
| File | HTP | Class 1 | Orthopedic | No | 2008-07-25 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1999-12-20 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2012-11-29 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 1999-12-20 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2005-11-09 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2013-07-25 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2018-01-22 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 1999-12-20 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2025-07-31 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1999-12-20 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-12-19 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1999-12-20 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2009-04-20 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2008-12-19 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2010-02-01 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2000-02-04 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2018-01-22 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-02-14 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2000-01-13 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1999-12-20 |
| Dilator, Urethral, Mechanical | FAH | Class 2 | Gastroenterology, Urology | No | 2025-02-14 |
| Dilator, Catheter, Ureteral | EZN | Class 2 | Gastroenterology, Urology | No | 2025-02-14 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2025-02-14 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2025-02-14 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2012-12-04 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 1992-12-08 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-06-25 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2014-09-26 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2012-11-13 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2000-01-13 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2012-12-04 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2018-01-22 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2018-01-22 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2013-03-18 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2008-11-14 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2009-02-05 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1999-12-20 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2014-02-26 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2020-06-04 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2014-04-14 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2024-02-20 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2010-02-02 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2019-02-06 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2013-01-21 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2010-02-18 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2012-12-04 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 1999-12-20 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2016-07-04 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2008-11-14 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2002-05-30 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2009-09-17 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2018-01-22 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 1999-12-20 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2000-02-28 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2024-04-09 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2012-09-23 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2011-12-22 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2023-07-27 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-12-04 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2020-04-01 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 1992-12-08 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2020-12-04 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2020-04-01 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-06-11 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 1999-12-20 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2018-02-19 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1999-12-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-03-06 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2012-12-04 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2016-11-02 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2013-08-28 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2008-11-14 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1999-12-20 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1999-12-20 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2008-07-25 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2024-02-20 |
| Probe | HXB | Class 1 | Orthopedic | No | 2012-04-19 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2014-07-08 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2012-09-13 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2019-10-25 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2000-01-13 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2018-01-22 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1999-12-20 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2020-07-08 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2017-10-24 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2008-07-25 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-02-14 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 1999-12-20 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2022-02-18 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2018-12-18 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2023-07-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2022-02-16 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2004-09-15 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2002-07-24 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2024-07-08 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2014-04-01 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-06-17 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2009-04-16 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2018-02-26 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2023-07-27 |
| Probe, Test, Heart-Valve | LXN | Class 1 | Cardiovascular | No | 2017-04-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2008-06-09 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2020-10-21 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1999-12-20 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 1999-12-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-02-14 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 2018-03-23 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2025-02-14 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 1999-12-20 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2012-09-13 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 1999-12-20 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2017-04-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-12-22 |
Proprietary Names
GROSSMAN FACIAL ELEV 6-3/4
Ball Probe medium
Ball Probe large
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)