FDA Registration
Active
🇩🇪 Germany
Eurofins STERIPAC GMBH
Reg #: 3009217531
·
FEI: 3009217531
·
Expires 2026
Products
60
Proprietary Names
0
Establishment Types
1
Classifications
60
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Registration Details
- Registration Name
- Eurofins STERIPAC GMBH
- Registration Number
- 3009217531
- FEI Number
- 3009217531
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Eurofins STERIPAC GMBH, Oberreichenbacherstr. 15-17
- City
- Calw-Altburg Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- STERIPAC GMBH
- Operator Number
- 10042503
- Address
- STERIPAC GMBH, Oberreichenbacherstr. 17
- City
- Calw-Altburg
- State
- Baden-Wurttemberg
- Postal Code
- 75365
- Country
- DE
- Correspondent
- Bettina E Wappler
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 |
|---|---|---|---|---|---|
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2023-12-15 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-12-15 |
| Clip, Aneurysm | HCH | Class 2 | Neurology | No | 2019-12-16 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2019-12-12 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2019-12-12 |
| Replacement, Ossicular Prosthesis, Total | ETA | Class 2 | Ear, Nose, Throat | No | 2019-12-12 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2020-12-17 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2025-12-18 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2018-12-19 |
| Prosthesis, Partial Ossicular Replacement | ETB | Class 2 | Ear, Nose, Throat | No | 2019-12-12 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2025-12-18 |
| Dilator, Esophageal | KNQ | Class 2 | Gastroenterology, Urology | No | 2019-12-12 |
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2012-12-04 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2018-12-19 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2020-12-17 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2020-12-17 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2019-12-16 |
| Device, Analysis, Anterior Segment | MXK | Class 2 | Ophthalmic | No | 2020-12-17 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2019-12-12 |
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | Class 2 | Neurology | No | 2024-12-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-12-19 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2023-12-15 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2020-12-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2019-12-12 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2018-12-19 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2019-12-12 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2023-12-15 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2023-12-15 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-12-15 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2025-12-18 |
| Endoscope, Ac-Powered And Accessories | GCP | Class 2 | Gastroenterology, Urology | No | 2019-12-12 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2023-12-15 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2025-12-18 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-12-16 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2018-12-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-12-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2018-12-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-12-18 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2025-12-18 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2019-12-16 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2019-12-12 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2019-12-16 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-12-18 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2018-12-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-12-12 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2017-12-18 |
| Instrument, Special Lens, For Endoscope | FEI | Class 1 | Gastroenterology, Urology | No | 2019-12-12 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2019-12-12 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2025-12-18 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-12-12 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2025-12-18 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2019-12-12 |
| Endoscopic Electrosurgical Clip Cutting System | QAG | Class 2 | Obstetrics/Gynecology | No | 2019-12-12 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2020-12-17 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2019-12-12 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2019-12-16 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2020-12-17 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2025-12-18 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2019-12-16 |
| Weights, Eyelid, External | MML | Class 2 | Ophthalmic | No | 2019-12-12 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)