FDA Registration
Active
🇪🇸 Spain
OPTOMIC ESPANA, S.A.
Reg #: 9617248
·
FEI: 3005435924
·
Expires 2026
Products
11
Proprietary Names
16
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- OPTOMIC ESPANA, S.A.
- Registration Number
- 9617248
- FEI Number
- 3005435924
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MADRONO 4F, POL. IND. LA MINA
- City
- COLMENAR VIEJO Madrid (Province)
- Country
- ES
Owner / Operator
- Firm Name
- OPTOMIC ESPANA, S.A.
- Operator Number
- 9037801
- Address
- MADRONO 4, POL IND LA MINA
- City
- COLMENAR VIEJO
- State
- Madrid (Province)
- Postal Code
- 28770
- Country
- ES
- Correspondent
- Pablo D - RIAL HUTT
US Agent
- Business Name
- Spain-US Chamber of Commerce
- Contact Name
- Nicolas Fontanillas
- Address
- 2153 Coral Way Suite 400
- City
- Miami
- State
- FL
- ZIP
- 33145
- Country
- US
- [email protected]
- Phone
- 305 3585988
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 1999-04-27 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2013-02-11 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2013-02-11 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2003-09-10 |
| Camera, Television, Microsurgical, Without Audio | FWD | Class 1 | General, Plastic Surgery | No | 1999-04-27 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 1999-04-27 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 1999-04-27 |
| Unit, Examining/Treatment, Ent | ETF | Class 1 | Ear, Nose, Throat | No | 2013-02-11 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2004-02-26 |
| Colposcope (And Colpomicroscope), Exempt | PTZ | Class 2 | Obstetrics/Gynecology | No | 2019-05-10 |
| Chair, Surgical, Ac-Powered | GBB | Class 1 | General, Plastic Surgery | No | 2013-02-11 |
Proprietary Names
OPTOMIC FIBEROPTIC LIGHT SOURCES
OPTOMIC LARYNGOSCOPES
OPTOMIC OTOSCOPES
STROBOLUX III
STROBOLUX II
OPTOMIC ENDOSCOPIC CAMERAS
OPTOMIC EXAMINATION AND SURGICAL MICROSCOPES
EXAMINATION STEREO MICROS
EXAMINATION STEREO MICROSCOPES
OPTOMIC ENT EXAMINATION AND TREATMENT UNITS
OPTOMIC FLEXIBLE ENDOSCOPES
OPTOMIC OP-C2L
OPTOMIC OP-C5
OPTOMIC OP-C2
OPTOMIC SURGICAL AND EXAMINATION CHAIRS
OP-G7
Establishment Types
Manufacture Medical Device