FDA Registration
Active
🇮🇳 India
EPSILON EYE CARE PVT., LTD.
Reg #: 3003039352
·
FEI: 3003039352
·
Expires 2026
Products
42
Proprietary Names
2
Establishment Types
1
Classifications
42
Registration Details
- Registration Name
- EPSILON EYE CARE PVT., LTD.
- Registration Number
- 3003039352
- FEI Number
- 3003039352
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6B-301 SHWETA, ASHANAGAR WEH, Kandivali (E)
- City
- MUMBAI Maharashtra
- Country
- IN
Owner / Operator
- Firm Name
- EPSILON EYE CARE PVT., LTD.
- Operator Number
- 9042394
- Address
- 6B-301 SHWETA, ASHANAGAR, WESTERN EXPRESS HWY.
- City
- Kandivali (E), MUMBAI
- State
- Maharashtra
- Postal Code
- 400-066
- Country
- IN
US Agent
- Business Name
- FOCUS OPHTHALMICS, LLC
- Contact Name
- MOHAMMED IBRAHIM
- Address
- 13851 Roswell Ave Ste I
- City
- Chino
- State
- CA
- ZIP
- 91710
- Country
- US
- [email protected]
- Phone
- 909 9844614
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2013-08-13 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2000-08-02 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2000-08-02 |
| Snare, Enucleating | HNE | Class 1 | Ophthalmic | No | 2000-08-02 |
| Trabeculotome | HMZ | Class 1 | Ophthalmic | No | 2000-08-02 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2000-08-02 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2000-08-02 |
| Erisophake | HNT | Class 1 | Ophthalmic | No | 2000-08-02 |
| Collagen Corneal Shield | MOE | Class 1 | Ophthalmic | No | 2000-08-02 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2000-08-02 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2000-08-02 |
| Rongeur, Lachrymal Sac | HNG | Class 1 | Ophthalmic | No | 2000-08-02 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2000-08-02 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 2013-01-02 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2000-08-02 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2000-08-02 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2000-08-02 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2013-01-02 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2000-08-02 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 2000-08-02 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2013-08-13 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2013-01-02 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2000-08-02 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2013-01-02 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2000-08-02 |
| Expressor | HNS | Class 1 | Ophthalmic | No | 2000-08-02 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2000-08-02 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2000-08-02 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2013-08-13 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2013-08-13 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2000-08-02 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2013-01-02 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2000-08-02 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2000-08-02 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2000-08-02 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2000-08-02 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
Proprietary Names
Epsilon
EPSILON
Establishment Types
Manufacture Medical Device