FDA Registration
Active
🇩🇪 Germany
A.HANDTE MEDIZINTECHNIK GMBH & CO. KG
Reg #: 8010155
·
FEI: 4476
·
Expires 2026
Products
62
Proprietary Names
1
Establishment Types
1
Classifications
62
Registration Details
- Registration Name
- A.HANDTE MEDIZINTECHNIK GMBH & CO. KG
- Registration Number
- 8010155
- FEI Number
- 4476
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- EHRENBERGSTRASSE 39
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- A.HANDTE MEDIZINTECHNIK GMBH & CO. KG
- Operator Number
- 8010155
- Address
- EHRENBERGSTRASSE 39, --
- City
- TUTTLINGEN
- State
- DE-NOTA
- Postal Code
- D-78532
- Country
- DE
- Correspondent
- Philip - HANDTE
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 |
|---|---|---|---|---|---|
| Curette, Operative | EKE | Class 1 | Dental | No | 1978-03-22 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 1978-03-22 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2018-07-25 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 1978-03-22 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 1978-03-22 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 1978-03-22 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2002-07-24 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1978-03-22 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 1978-03-22 |
| Pinwheel | GWY | Class 1 | Neurology | No | 1978-03-22 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 1978-03-22 |
| Perforator, Antrum | KAT | Class 1 | Ear, Nose, Throat | No | 2002-07-24 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 1978-03-22 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 1978-03-22 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 1997-11-24 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 1978-03-22 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 1978-03-22 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 1978-03-22 |
| Hook, Tonsil Suturing | KBP | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Gauge, Mastoid | JYI | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Impactor | HWA | Class 1 | Orthopedic | No | 1978-03-22 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Rasp, Frontal-Sinus | KAZ | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 1997-11-24 |
| File | HTP | Class 1 | Orthopedic | No | 1978-03-22 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2018-07-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 1978-03-22 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1997-11-24 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1978-03-22 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Spoon, Ear | JZE | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 1997-11-24 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 1978-03-22 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 1978-03-22 |
| Chisel, Mastoid | JYD | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 1978-03-22 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2000-05-10 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 1978-03-22 |
Proprietary Names
WELLAMINSKI ANTRUM PERFO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)