FDA Registration
Active
🇩🇪 Germany
HAFNER CHIRURGISCHE INSTRUMENTE
Reg #: 3003435550
·
FEI: 3003435550
·
Expires 2026
Products
57
Proprietary Names
0
Establishment Types
2
Classifications
57
Registration Details
- Registration Name
- HAFNER CHIRURGISCHE INSTRUMENTE
- Registration Number
- 3003435550
- FEI Number
- 3003435550
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ringstrasse 5
- City
- BALGHEIM Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- HAFNER CHIRURGISCHE INSTRUMENTE
- Operator Number
- 9046961
- Address
- Ringstrasse 5, --
- City
- BALGHEIM
- State
- Baden-Wurttemberg
- Postal Code
- 78582
- Country
- DE
US Agent
- Business Name
- BSI Business Support International
- Contact Name
- Angelika Scherp
- Address
- 1350 Avenue of the Americas, 2nd Floor
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 212 3318358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2017-10-17 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2022-01-19 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2003-01-31 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-03-16 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2017-04-06 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2003-01-31 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2025-04-21 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2023-01-17 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2003-01-31 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2024-04-28 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2003-01-31 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2026-05-13 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2025-01-22 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2021-02-22 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2022-11-17 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2003-01-31 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2013-06-13 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2013-01-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-09-02 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2003-01-31 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2024-08-26 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-03-31 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2023-10-18 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-04-13 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 2023-07-07 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2025-05-12 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2003-01-31 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2023-03-31 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2017-06-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-28 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2018-01-27 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2025-11-23 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2022-11-17 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-10-23 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2024-03-16 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2022-04-11 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2023-10-30 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2025-12-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-03-16 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2003-01-31 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-06-13 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2024-11-18 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2019-10-26 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2024-01-21 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2003-01-31 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2019-04-10 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2020-03-14 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2003-01-31 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2022-05-13 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2003-01-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-10-26 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2017-10-26 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2018-01-27 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2022-12-18 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2003-01-31 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-12-17 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2024-04-09 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device