FDA Registration
Active
🇮🇳 India
KDANS SURGICAL PRIVATE LIMITED
Reg #: 9617768
·
FEI: 1000246164
·
Expires 2026
Products
32
Proprietary Names
31
Establishment Types
2
Classifications
32
Registration Details
- Registration Name
- KDANS SURGICAL PRIVATE LIMITED
- Registration Number
- 9617768
- FEI Number
- 1000246164
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- G.I. D.C. INDUSTRIAL ESTATE, PLOT No. 701-703, SECTOR 28
- City
- GANDHINAGAR Gujarat
- Country
- IN
Owner / Operator
- Firm Name
- KDANS SURGICAL PRIVATE LIMITED
- Operator Number
- 9039272
- Address
- G.I. D.C. INDUSTRIAL ESTATE, PLOT # 701-703, SECTOR 28
- City
- GANDHINAGAR
- State
- IN-NOTA
- Postal Code
- 382028
- Country
- IN
US Agent
- Business Name
- Stephens Instruments
- Contact Name
- Archna Johnson
- Address
- 2500 Sandersville Rd
- City
- Lexington
- State
- KY
- ZIP
- 40511
- Country
- US
- [email protected]
- Phone
- 859 2594925
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1999-10-08 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 1999-10-08 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 1999-10-08 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1999-10-08 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2000-09-07 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 1999-10-08 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1999-10-08 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2001-06-11 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 1999-10-08 |
| Snare, Enucleating | HNE | Class 1 | Ophthalmic | No | 1999-10-08 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2000-09-07 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-04-15 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1999-10-08 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2000-09-07 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2000-09-07 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1999-10-08 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2007-03-23 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1999-10-08 |
| Chair, Neurosurgical | HBN | Class 1 | Neurology | No | 1999-10-08 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 1999-10-08 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 1999-10-08 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 2007-03-23 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 1999-10-08 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 1999-10-08 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 1999-10-08 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 1999-10-08 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2000-09-07 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1999-10-08 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 1999-10-08 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2000-09-07 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2000-09-07 |
| Erisophake | HNT | Class 1 | Ophthalmic | No | 2000-09-07 |
Proprietary Names
Dilator, lachrymal
Clip, iris retractor
Caliper, ophthalmic
Forceps, ophthalmic
Set, lens, trial, ophthalmic
Clamp, muscle, ophthalmic
TRAY, SURGICAL, INSTRUMENT
Trephine, manual, ophthalmic
Cystotome
Snare, enucleating
Spatula, ophthalmic
Knife, ophthalmic
Marker, sclera
Frame, trial, ophthalmic
Cannula, ophthalmic
Probe, lachrymal
SCISSORS, OPHTHALMIC
CHAIR, NEUROSURGICAL
Depressor, orbital
UNIT, SYRINGE, AIR AND/OR WATER
Burr, corneal, manual
Spud, ophthalmic
Clamp, eyelid, ophthalmic
Curette, ophthalmic
Punch, corneo-scleral
NEEDLE, ASPIRATION AND INJECTION, REUSABLE
Hook, ophthalmic
Retractor, ophthalmic
Specula, ophthalmic
RING, OPHTHALMIC (FLIERINGA)
Erisophake
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device