FDA Registration
Active
🇩🇪 Germany
AMNOTEC INTERNATIONAL MEDICAL GMBH
Reg #: 3014615697
·
FEI: 3014615697
·
Expires 2026
Products
119
Proprietary Names
1
Establishment Types
1
Classifications
119
Registration Details
- Registration Name
- AMNOTEC INTERNATIONAL MEDICAL GMBH
- Registration Number
- 3014615697
- FEI Number
- 3014615697
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Take-Off-Gewerbepark 12
- City
- Neuhausen ob Eck Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K080560
Owner / Operator
- Firm Name
- Amnotec International Medical GmbH
- Operator Number
- 10057846
- Address
- Take-Off-Gewerbepark 12
- City
- Neuhausen ob Eck
- State
- Baden-Wurttemberg
- Postal Code
- 78579
- Country
- DE
- Correspondent
- Milorad Perazic
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 |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2021-07-11 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2023-06-15 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2022-06-21 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2018-06-27 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2018-06-26 |
| Trocar, Tracheal | KCI | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2021-07-11 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2021-07-11 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2018-07-09 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2019-08-28 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2018-06-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-09-02 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2021-07-12 |
| Lithotriptor, Biliary Mechanical | LQC | Class 2 | Gastroenterology, Urology | No | 2021-07-27 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2018-06-02 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2018-06-26 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2018-08-21 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Trocar, Sinus | KBG | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2018-06-27 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2018-07-08 |
| Forceps, Wire Closure, Ent, Sterile | JXX | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2018-07-08 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2018-07-09 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2021-07-11 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2020-06-25 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2018-07-08 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2018-07-08 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2018-06-27 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2018-07-08 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2018-07-07 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2018-07-08 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2018-06-27 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-07-08 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Spoon, Ear | JZE | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2018-06-26 |
| Snare, Ear | JZD | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2018-07-08 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2021-07-27 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2021-09-10 |
| Cannula, Ear | JYC | Class 1 | General, Plastic Surgery | No | 2018-07-08 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2018-06-26 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2018-07-08 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2018-07-08 |
| Pinwheel | GWY | Class 1 | Neurology | No | 2018-06-28 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2018-07-09 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2018-07-08 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2018-07-08 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2018-07-02 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Applier, Hemostatic Clip | HBT | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2018-07-08 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2018-07-07 |
| Punch, Skull | GXJ | Class 1 | Neurology | No | 2018-06-28 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2018-07-07 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2018-06-27 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2022-12-14 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2018-07-08 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2021-07-11 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2021-09-10 |
| Clamp, Ossicle Holding | JYF | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2018-07-08 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2018-06-27 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2019-08-28 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2018-06-27 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2018-07-02 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2018-07-09 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-07-08 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2018-07-09 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2018-06-27 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Guillotine, Tonsil | KBO | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2018-06-26 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2018-07-10 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2018-07-07 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2021-09-10 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2018-07-07 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2018-06-26 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2021-06-11 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2018-06-26 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2018-06-26 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2018-07-09 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2018-07-08 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Chisel, Mastoid | JYD | Class 1 | General, Plastic Surgery | No | 2018-07-08 |
| Halter, Head, Traction | HSS | Class 1 | Orthopedic | No | 2018-07-08 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2018-06-28 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-06-27 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2018-06-26 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2018-07-08 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2018-07-08 |
| Probe | HXB | Class 1 | Orthopedic | No | 2018-07-08 |
Proprietary Names
London College
Establishment Types
Repack or Relabel Medical Device