FDA Registration
Active
🇫🇷 France
CEFIMECA
Reg #: 3006563559
·
FEI: 3006563559
·
Expires 2026
Products
54
Proprietary Names
4
Establishment Types
1
Classifications
54
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Registration Details
- Registration Name
- CEFIMECA
- Registration Number
- 3006563559
- FEI Number
- 3006563559
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15 rue de la Chazotte
- City
- La Talaudiere Loire
- Country
- FR
Owner / Operator
- Firm Name
- Cefimeca
- Operator Number
- 10035460
- Address
- 15 rue de la Chazotte
- City
- La Talaudiere
- State
- Loire
- Postal Code
- 42350
- Country
- FR
- Correspondent
- Frederic Mazenod
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 |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-12-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-02-28 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2016-02-24 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2016-02-24 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2023-06-21 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2025-05-12 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2016-02-24 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-05-12 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2025-05-12 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2023-06-21 |
| Haploscope | HJT | Class 1 | Ophthalmic | No | 2021-02-25 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2016-02-24 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-06-21 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-06-21 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2023-06-21 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2018-12-28 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2018-04-16 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2018-02-05 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2018-02-05 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2016-02-24 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-06-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-06-21 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2023-06-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-02-05 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2016-02-24 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-06-21 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-06-21 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2016-02-24 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-02-20 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-12-18 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2023-06-21 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2023-06-21 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2017-01-09 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2023-06-21 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-12-18 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-05-12 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2023-06-21 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2017-03-14 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2019-12-30 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2017-01-09 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-12-18 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2016-02-24 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2018-02-05 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-12-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-12-28 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2018-02-05 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2018-12-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2015-01-09 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2020-07-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-06-21 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2018-02-05 |
| Bender | HXW | Class 1 | Orthopedic | No | 2023-06-21 |
Proprietary Names
Idys ALIF 3DTi
Erisma LP
JARVIS Glenoid Reverse Shoulder Prosthesis
AEQUALIS PerFORM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)