FDA Registration
Active
🇩🇪 Germany
OERTEL MEDICAL GMBH
Reg #: 9612075
·
FEI: 3002809480
·
Expires 2026
Products
65
Proprietary Names
3
Establishment Types
1
Classifications
65
Registration Details
- Registration Name
- OERTEL MEDICAL GMBH
- Registration Number
- 9612075
- FEI Number
- 3002809480
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- OBERE VORSTADT 19-20
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- OERTEL MEDICAL GMBH
- Operator Number
- 8010226
- Address
- OBERE VORSTADT 19-20, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- D-78532
- Country
- DE
US Agent
- Business Name
- BUSINESS SUPPORT INTERNATIONAL
- Contact Name
- Angelika Scherp
- Address
- 1350 Avenue Of The Americas FL 2
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 212 3318358 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1994-03-07 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 1998-06-08 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 1986-06-24 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 1984-09-07 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2013-01-16 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2000-04-13 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2013-01-16 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1992-10-17 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 1996-11-05 |
| Probe | HXB | Class 1 | Orthopedic | No | 2003-08-07 |
| Hook, Fibroid, Gynecological | HDE | Class 1 | Obstetrics/Gynecology | No | 2010-03-24 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 1994-04-25 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2013-01-16 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 1984-09-07 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 1983-09-27 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1992-10-17 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1986-06-24 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-01-16 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 1994-04-25 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 1994-01-05 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1994-04-25 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 1984-09-07 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1986-06-24 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 1997-04-02 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1986-06-24 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1986-06-24 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 1992-10-17 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 1983-09-27 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2013-01-16 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 1994-06-08 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 1999-06-07 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 1992-10-17 |
| Tamp | HXG | Class 1 | Orthopedic | No | 1997-05-23 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1978-04-25 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1986-06-24 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2013-01-16 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2000-03-22 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2013-03-04 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 1983-09-27 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2013-01-16 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2010-06-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-16 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2000-08-02 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 1984-09-07 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 1996-11-05 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-03-04 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1997-01-17 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2000-03-22 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1978-04-25 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2011-11-21 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1994-03-07 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1997-01-17 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1986-06-24 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 1996-11-05 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2010-03-24 |
| Awl | HWJ | Class 1 | Orthopedic | No | 1994-04-25 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 1999-08-10 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 1994-03-07 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2013-01-16 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 1996-11-05 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2010-03-24 |
| Trocar, Sinus | KBG | Class 1 | Ear, Nose, Throat | No | 1996-11-05 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 1997-01-17 |
| Hook, Gastro-Urology | FHB | Class 1 | Gastroenterology, Urology | No | 1994-04-25 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1994-06-08 |
Proprietary Names
Curette, Nasal
RASP
Retractor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)