FDA Registration
Active
🇩🇪 Germany
EVONOS GMBH & CO. KG
Reg #: 3010726901
·
FEI: 3010726901
·
Expires 2026
Products
64
Proprietary Names
5
Establishment Types
2
Classifications
64
Registration Details
- Registration Name
- EVONOS GMBH & CO. KG
- Registration Number
- 3010726901
- FEI Number
- 3010726901
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Stockacher Strasse 134
- City
- Tuttlingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K231403
Owner / Operator
- Firm Name
- evonos GmbH & Co. KG
- Operator Number
- 10048205
- Address
- Stockacher Strasse 134
- City
- Tuttlingen
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
- Correspondent
- Joerg Mans
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 |
|---|---|---|---|---|---|
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2018-07-19 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Brush, Biopsy, General & Plastic Surgery | GEE | Class 1 | General, Plastic Surgery | No | 2016-06-30 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-09-11 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2018-07-19 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Press, Vein | JYW | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2018-07-19 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-09-11 |
| Mirror, Headband, Ophthalmic | HKF | Class 1 | Ophthalmic | No | 2015-04-23 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2018-03-13 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2018-07-19 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2015-04-23 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2024-04-17 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Inserter, Myringotomy Tube | JYM | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Hoe, Periodontic | EMQ | Class 1 | Dental | No | 2018-07-19 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Perforator, Ear-Lobe | JYS | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2018-07-19 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-02-09 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Jig, Piston Cutting, Ent, Non-Sterile | NNO | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2018-07-19 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2018-03-13 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2015-04-22 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Transilluminator, Fiber Optic | MQW | Class 1 | Ear, Nose, Throat | No | 2018-03-02 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2015-04-23 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2016-07-01 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2022-06-24 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2015-04-23 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 2018-07-19 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2015-04-23 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2018-07-19 |
Proprietary Names
Sickle knife "Richards", sharp, size 190
Suction tube "Velvet Eye", tip closed, with 2 lateral holes, size 220
WILLIAMS MICROCLIP INSERTER
Osteotome, acc. to Sheehan, hexagonal handle, straight, size 3 x 160
Osteotome, acc. to Sheehan, hexagonal handle, straight, size 8 x 160
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)