FDA Registration
Active
🇲🇽 Mexico
Devicor Medical Products de Mexico S de RL de CV
Reg #: 3008992312
·
FEI: 3008992312
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Devicor Medical Products de Mexico S de RL de CV
- Registration Number
- 3008992312
- FEI Number
- 3008992312
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sor Juana Ines de la Cruz #20152 4-B, Parque Industrial Chilpancingo
- City
- Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K152989
Owner / Operator
- Firm Name
- Devicor Medical Products, Inc.
- Operator Number
- 10033297
- Address
- 300 E-Business Way, Fifth Floor
- City
- Cincinnati
- State
- OH
- Postal Code
- 45241
- Country
- US
- Correspondent
- Katrine M Austin
US Agent
- Business Name
- Devicor Medical Products, Inc.
- Contact Name
- Katrine Austin
- Address
- 300 E-Business Way, Fifth Floor
- City
- Cincinnati
- State
- OH
- ZIP
- 45241
- Country
- US
- [email protected]
- Phone
- 513 2051196
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2016-03-16 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2016-12-05 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2010-07-30 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2020-12-17 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2010-07-30 |
Proprietary Names
Mammotome revolve
Mammotome
Mammotome® EX Hand Held System
Mammotome elite Biopsy System
Mammotome® System Disposable Probe
Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System
Mammotome® Hand Held 8 Gauge System
Hydromark
HydroMark Breast Biopsy Site Marker
HydroMARK Plus
Mammotome AutoCore Single Insertion Core Biopsy System
Mammotome® Hand Held System
Mammotome revolve EX
HydroMARK Plus Breast Biopsy Site Marker
LumiMARK Biopsy Site Marker
Mammotome® Biopsy System
MammoMark¿ MR Biopsy Identifier
CorMARK¿ Biopsy Identifier
MammoMark¿ Biopsy Identifier
HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
Mammotome® MR Biopsy System
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device