FDA Registration
Active
🇩🇪 Germany
Berger Surgical Medical Products GmbH
Reg #: 3013784566
·
FEI: 3013784566
·
Expires 2026
Products
70
Proprietary Names
7
Establishment Types
3
Classifications
70
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Registration Details
- Registration Name
- Berger Surgical Medical Products GmbH
- Registration Number
- 3013784566
- FEI Number
- 3013784566
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- take-off GewerbePark 4
- City
- Neuhausen ob Eck Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- Berger Surgical Medical Products GmbH
- Operator Number
- 10055726
- Address
- take-off-Gewerbepark 4
- City
- Neuhausen ob Eck
- State
- Baden-Wurttemberg
- Postal Code
- 78579
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2021-01-10 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2020-12-08 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2021-01-10 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| Instrument, Clip Removal | HBQ | Class 1 | Neurology | No | 2021-01-10 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2020-12-21 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2025-05-14 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2021-01-10 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2020-12-21 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2020-12-21 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2025-05-14 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2020-12-21 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2020-12-08 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2021-01-10 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2021-01-10 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2020-12-21 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2020-12-21 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2020-12-21 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2021-01-10 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Probe | HXB | Class 1 | Orthopedic | No | 2021-01-10 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2025-05-12 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2021-01-10 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2020-12-21 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2021-01-10 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2021-01-10 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2021-01-10 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2020-12-21 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2017-09-26 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2020-12-21 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2020-12-21 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2020-02-10 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2021-01-10 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2021-01-10 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2021-01-10 |
Proprietary Names
LOFTUS 2-Level ACDF Distractor
Septal Hook - Retractor
Septal Hook, 3 prong, 7mm hook, angled up and ot the side
De Bakey Forceps titanium, 240 mm length
Septal Hook, 3 prong, 13 mm hook, angled up and ot the side
Septal Hook, 3 prong, 10 mm hook, angled up and ot the side
De Bakey Forceps titanium, 195 mm length
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Remanufacture Medical Device