FDA Registration
Active
🇮🇹 Italy
OEB S.R.L.
Reg #: 3013791180
·
FEI: 3013791180
·
Expires 2026
Products
22
Proprietary Names
27
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- OEB S.R.L.
- Registration Number
- 3013791180
- FEI Number
- 3013791180
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Circonvallazione, 9
- City
- Camposanto Modena
- Country
- IT
Owner / Operator
- Firm Name
- OEB S.r.l.
- Operator Number
- 10092438
- Address
- Via Circonvallazione, 9
- City
- Camposanto
- State
- Modena
- Postal Code
- 41031
- Country
- IT
- Correspondent
- Andrea Dondi
US Agent
- Business Name
- Mellingen Consulting
- Contact Name
- SHERRI MELLINGEN
- Address
- 7205 Dahlgren Rd
- City
- Chaska
- State
- MN
- ZIP
- 55318
- Country
- US
- [email protected]
- Phone
- 952 9136383
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2025-02-14 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-01-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2025-02-14 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-02-19 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2025-02-14 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2026-01-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2025-02-14 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2025-02-19 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2026-01-15 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2026-01-15 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2025-02-14 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2025-02-19 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2025-02-14 |
| Template | HWT | Class 1 | Orthopedic | No | 2026-01-15 |
Proprietary Names
SMR TT Augmented Glenoid System
SMR TT METAL BACK GLENOID
SMR 140° Reverse Humeral Body
AMF Revision TT Cones
Guide, surgical, instrument
SMR Shoulder System
SMR Finned Short Stems
Revision Femoral Stem
Orthopedic manual surgical instrument
PRIMA Humeral System
SMR Glenosphere Dia.42
accessory/attachment
Delta TT Cups; Delta Liners
EXTRACTOR
TEMA Elbow System
PRIMA TT Glenoid
PHYSICA KR KNEE SYSTEM
SMR TT Metal Back Glenoid Bone Graft instruments
WRENCH
SMR Stemless Anatomic
Physica CR Knee System
Template
SMR 3-PEGS GLENOIDS
SMR Hybrid Glenoid System
Delta Dual Mobility System
PRIMA Humeral System; PRIMA TT Glenoid
SMR 3-Pegs Glenoids
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)