FDA Registration
Active
🇺🇸 United States
TECFEN MEDICAL
Reg #: 3010487482
·
FEI: 3010487482
·
Expires 2026
Products
21
Proprietary Names
23
Establishment Types
2
Classifications
21
Registration Details
- Registration Name
- TECFEN MEDICAL
- Registration Number
- 3010487482
- FEI Number
- 3010487482
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6100 HOLLISTER AVENUE, Building 3, Unit 3A/3B
- City
- Santa Barbara
- State
- CA
- ZIP
- 93117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191846
Owner / Operator
- Firm Name
- TECFEN MEDICAL
- Operator Number
- 10047971
- Address
- 6100 Hollister Avenue, Building 3, Unit 3A/3B
- City
- Santa Barbara
- State
- CA
- Postal Code
- 93117
- Country
- US
- Correspondent
- GENE EKONOMI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2020-11-23 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2015-03-17 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-09-08 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2016-08-09 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-06-24 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2015-03-17 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2014-12-03 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2021-03-15 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2018-03-14 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2019-03-20 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2023-07-28 |
| Kit, Earmold, Impression | LDG | Class 1 | Ear, Nose, Throat | No | 2015-04-28 |
| Drape, Patient, Ophthalmic | HMT | Class 2 | General, Plastic Surgery | No | 2016-08-31 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2015-04-03 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2015-04-28 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2014-11-20 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2019-03-20 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2015-03-19 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2019-04-04 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2019-03-20 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2020-04-22 |
Proprietary Names
Tecfen Laser Probes
Tecfen Thermometer
Tecfen Medical Face Shield
Eye Shield
Tecfen Medical goggles
Tecfen Medical Tape
Tecfen Trephine
Tecfen Ophthalmic Knife
Tecfen Medical Intranasal Septal Splint
Tecfen Iris Retractor
Tecfen Skin Marker
Tecfen sponges, spears, wipes, wicks
Tecfen PVA and Cellulose Product
Tecfen Silicone Ear Plug
Ophthalmic Patient Drape
Tecfen Otological Ventilation Tube
Tecfen Ophthalmic Cannula
Tecfen Keratome Blade
Tecfen Ophthalmic Hook
Tecfen Punctum Plug
Tecfen Sunglasses
Tecfen Surgical Drape
Surgical Drape
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility