FDA Registration
Active
🇸🇰 Slovakia
BIS MASTERMED
Reg #: 3030451558
·
FEI: 3030451558
·
Expires 2026
Products
33
Proprietary Names
1
Establishment Types
3
Classifications
33
Registration Details
- Registration Name
- BIS MASTERMED
- Registration Number
- 3030451558
- FEI Number
- 3030451558
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Juzna trieda 119
- City
- Kosice Kosicky
- Country
- SK
Owner / Operator
- Firm Name
- BIS MASTERMED s.r.o.
- Operator Number
- 10089528
- Address
- Juzna trieda 119
- City
- Kosice
- State
- Kosicky
- Postal Code
- 04001
- Country
- SK
- Correspondent
- Veronika Krausova
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 2023-12-22 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2023-12-22 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2023-12-22 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2023-12-22 |
| Trabeculotome | HMZ | Class 1 | Ophthalmic | No | 2023-12-22 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2023-12-22 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2023-12-22 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2023-12-22 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2023-12-22 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2023-12-22 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2023-12-22 |
| Rongeur, Lachrymal Sac | HNG | Class 1 | Ophthalmic | No | 2023-12-22 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2023-12-22 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2023-12-22 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2023-12-14 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | Class 1 | Ophthalmic | No | 2023-12-22 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2023-12-14 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2023-12-14 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2023-12-22 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2023-12-22 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2023-12-22 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2023-12-22 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2023-12-22 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2023-12-22 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2023-12-14 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2023-12-14 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2023-12-22 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2023-12-22 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2023-12-22 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 2023-12-22 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2023-12-16 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2023-12-22 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2023-12-22 |
Proprietary Names
TITAN MEDICAL
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device