FDA Registration
Active
🇩🇪 Germany
ELCON MEDICAL INSTRUMENTS GMBH
Reg #: 8043816
·
FEI: 3005734757
·
Expires 2026
Products
74
Proprietary Names
0
Establishment Types
1
Classifications
74
Registration Details
- Registration Name
- ELCON MEDICAL INSTRUMENTS GMBH
- Registration Number
- 8043816
- FEI Number
- 3005734757
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- DR. KARL-STORZ-STRASSE 26A
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- ELCON MEDICAL INSTRUMENTS GMBH
- Operator Number
- 9003951
- Address
- DR. KARL-STORZ-STRASSE 26A, --
- City
- TUTTLINGEN
- State
- DE-NOTA
- Postal Code
- D-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 |
|---|---|---|---|---|---|
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 1992-04-28 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2005-02-04 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2008-05-29 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2021-01-18 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2021-01-18 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2021-01-18 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2005-02-04 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2006-05-26 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2021-01-15 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2005-02-04 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2006-05-26 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2005-02-04 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Mirror, General & Plastic Surgery | FTX | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 1992-05-11 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2005-02-04 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 1992-05-11 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1992-05-11 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2021-01-18 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2021-01-18 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 1992-05-11 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 1992-05-11 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1992-05-11 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2021-01-18 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 1992-05-11 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2005-02-04 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2021-01-18 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2021-01-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2021-01-18 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1992-04-28 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 1992-05-11 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2015-03-08 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2005-02-04 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2021-01-18 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 1992-05-11 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2021-01-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2009-09-14 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2005-02-04 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2008-02-28 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1992-03-17 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 1992-05-11 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1992-05-11 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2021-01-18 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2005-02-04 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2021-01-18 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2005-02-04 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2021-01-18 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2021-01-18 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2008-02-28 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2006-05-26 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2009-03-12 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2005-02-04 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2008-02-28 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2005-02-04 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2005-02-04 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2005-02-04 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 1992-04-28 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2005-02-04 |
| Perforator, Antrum | KAT | Class 1 | Ear, Nose, Throat | No | 2021-01-18 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2009-09-14 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1992-04-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2021-01-18 |
Establishment Types
Repack or Relabel Medical Device