FDA Registration
Active
🇩🇪 Germany
ADDN SOLUTIONS GMBH & CO. KG
Reg #: 3033536312
·
FEI: 3033536312
·
Expires 2026
Products
102
Proprietary Names
0
Establishment Types
1
Classifications
102
Registration Details
- Registration Name
- ADDN SOLUTIONS GMBH & CO. KG
- Registration Number
- 3033536312
- FEI Number
- 3033536312
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Max-Planck-Str. 12
- City
- Wurmlingen Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- addn solutions GmbH & Co. KG
- Operator Number
- 10091519
- Address
- Max-Planck-Str. 12
- City
- Wurmlingen
- State
- Baden-Wurttemberg
- Postal Code
- 78573
- Country
- DE
- Correspondent
- Dominik Buggle
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 |
|---|---|---|---|---|---|
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2024-11-04 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2024-11-04 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2024-11-04 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2024-11-04 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2024-11-04 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2024-11-04 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2024-11-04 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2024-11-04 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2024-11-04 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2024-11-04 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2024-11-04 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2024-11-04 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2024-11-04 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Bender | HXW | Class 1 | Orthopedic | No | 2024-11-04 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2024-11-04 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2024-11-04 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2024-11-04 |
| Instrument, Clip Removal | HBQ | Class 1 | Neurology | No | 2024-11-04 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2024-11-04 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2024-11-04 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2024-11-04 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2024-11-04 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2024-11-04 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2024-11-04 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2024-11-04 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2024-11-04 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2024-11-04 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2024-10-11 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2024-11-04 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2024-11-04 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2024-11-04 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2024-11-04 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2024-11-04 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2024-11-04 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2024-11-04 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-11-04 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2024-11-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-11-04 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2024-11-04 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Stripper, Artery, Intraluminal | DWX | Class 2 | Cardiovascular | No | 2024-11-04 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2024-11-04 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2024-11-04 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2024-11-04 |
| Forceps, Biopsy, Bronchoscope (Rigid) | JEK | Class 2 | Ear, Nose, Throat | No | 2024-11-04 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2024-11-04 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2024-11-04 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2024-11-04 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2024-11-04 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2024-11-04 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| File | HTP | Class 1 | Orthopedic | No | 2024-11-04 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2024-11-04 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2024-11-04 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2024-11-04 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-11-04 |
| Fork | HXE | Class 1 | Orthopedic | No | 2024-11-04 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2024-11-04 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2024-11-04 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2024-11-04 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2024-11-04 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)