FDA Registration
Active
🇩🇪 Germany
e.l. zepf GmbH
Reg #: 8010433
·
FEI: 3003200061
·
Expires 2026
Products
42
Proprietary Names
0
Establishment Types
2
Classifications
42
Registration Details
- Registration Name
- e.l. zepf GmbH
- Registration Number
- 8010433
- FEI Number
- 3003200061
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GOTENSTRASSE 5
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- e.l. zepf GmbH
- Operator Number
- 8010433
- Address
- GOTENSTRASSE 5, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- D-78532
- Country
- DE
US Agent
- Business Name
- Beate Weiss-Krull, Attorney at Law
- Contact Name
- Beate Weiss-Krull
- Address
- 1639 SE 58th Ave
- City
- Portland
- State
- OR
- ZIP
- 97215
- Country
- US
- [email protected]
- Phone
- 503 2340355
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 1997-02-12 |
| Bougie, Esophageal, Ent | KCD | Class 1 | Ear, Nose, Throat | No | 2004-07-19 |
| Dilator, Esophageal, Ent | KCF | Class 1 | Ear, Nose, Throat | No | 2004-07-19 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1986-08-20 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1978-06-28 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2015-06-19 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1979-06-01 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1997-02-12 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 1979-06-01 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1983-09-27 |
| Holder, Speculum, Ent | KAG | Class 1 | General, Plastic Surgery | No | 2004-07-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-12-11 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 1997-02-12 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1979-06-01 |
| Mobilizer, Ent | KAJ | Class 1 | Ear, Nose, Throat | No | 2004-07-19 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 1983-09-27 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2015-07-27 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2015-06-19 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2015-06-19 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 1983-09-27 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2015-06-19 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2015-06-19 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1978-06-28 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1986-10-30 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2004-07-19 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2015-11-25 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2004-07-19 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1997-02-12 |
| Bender | HXW | Class 1 | Orthopedic | No | 2023-06-21 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1983-09-27 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2015-06-19 |
| Curette, Ethmoid | KAO | Class 1 | Ear, Nose, Throat | No | 2015-06-19 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2015-06-19 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 1997-02-12 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2021-06-01 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2010-03-24 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2015-06-19 |
| Inserter, Myringotomy Tube | JYM | Class 1 | Ear, Nose, Throat | No | 2015-04-02 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)