FDA Registration
Active
🇩🇪 Germany
EUROFINS INPAC MEDIZINTECHNIK GMBH
Reg #: 3013111980
·
FEI: 3013111980
·
Expires 2026
Products
14
Proprietary Names
1
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- EUROFINS INPAC MEDIZINTECHNIK GMBH
- Registration Number
- 3013111980
- FEI Number
- 3013111980
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Neureutstrasse 4
- City
- Birkenfeld Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- Eurofins inpac Medizintechnik GmbH
- Operator Number
- 10043226
- Address
- Gewerbestrasse 34
- City
- Birkenfeld
- State
- Baden-Wurttemberg
- Postal Code
- 75217
- Country
- DE
- Correspondent
- Lisa Heilemann
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-02-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-05-19 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-06-22 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-02-26 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-02-26 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2015-08-03 |
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | Class 2 | Neurology | No | 2017-04-11 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2018-09-05 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2018-02-26 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2018-02-26 |
| Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | OXJ | Class 2 | General, Plastic Surgery | No | 2019-05-03 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2019-05-03 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2025-07-10 |
Proprietary Names
Spetzler Malis Standard and Slim Bipolar Forceps
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)