FDA Registration
Active
🇮🇹 Italy
ELMDOWN SRL UNIPERSONALE
Reg #: 3008572623
·
FEI: 3008572623
·
Expires 2026
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ELMDOWN SRL UNIPERSONALE
- Registration Number
- 3008572623
- FEI Number
- 3008572623
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- corso monforte 16
- City
- milano Lombardy
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K220131
- PMA Number
- N18466
Owner / Operator
- Firm Name
- elmdown srl unipersonale
- Operator Number
- 10040927
- Address
- corso monforte 16
- City
- milano
- State
- IT-MI
- Postal Code
- 20122
- Country
- IT
- Correspondent
- Michele Perrino
US Agent
- Business Name
- Brauer Device Consultants, LLC
- Contact Name
- Christine Brauer
- Address
- 33651 Summer Walk Unit 22004
- City
- Bethany Beach
- State
- DE
- ZIP
- 19930
- Country
- US
- [email protected]
- Phone
- 301 5451990
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2023-11-15 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-02-18 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2016-02-18 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2012-11-09 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2012-11-09 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device