FDA Registration
Active
🇨🇷 Costa Rica
HORIZONS INTL. CORP.
Reg #: 3004083736
·
FEI: 3004083736
·
Expires 2026
Products
11
Proprietary Names
21
Establishment Types
4
Classifications
11
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Registration Details
- Registration Name
- HORIZONS INTL. CORP.
- Registration Number
- 3004083736
- FEI Number
- 3004083736
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ZETA FREE ZONE PARK, LA VALENCIA
- City
- HEREDIA
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K011667
Owner / Operator
- Firm Name
- HORIZONS INTL. CORP.
- Operator Number
- 9040535
- Address
- ZETA FREE ZONE PARK, LA VALENCIA
- City
- HEREDIA
- State
- CR-NOTA
- Postal Code
- --
- Country
- CR
US Agent
- Business Name
- Miriam Oliveras
- Contact Name
- Miriam Oliveras
- Address
- Urb Ramey, 291 Circulo D
- City
- Aguadilla
- State
- PR
- ZIP
- 00603
- Country
- US
- [email protected]
- Phone
- 787 2989967
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2009-04-01 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2007-12-04 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2007-12-04 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2007-12-04 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2007-12-04 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2007-12-04 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2007-12-04 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2021-03-29 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2000-02-28 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2007-12-04 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2000-02-28 |
Proprietary Names
TWISTER PLUS RETRIEVAL DEVICE
Horizons International Polypectomy
Horizons Reusable Polypectomy Snare
Horizons International Varices Inje
Horizons Reusable Hot Biopsy Forcep
Horizons ANSO TransBronchial Aspira
Horizons Hot Biopsy Forceps
COBRA ROTATABEL SNARE AND POLYP C
TORNADO ROTATABEL SNARE AND POLYP C
Horizons Cleaning Brush
Stylet
ANSO Triple Needle Brush
Spin Xtend
ANSO TBNA
Cytology Brush
Biopsy Forceps
TWISTER
HORIZONS ENDOSCOPI
Horizons Cytology / Microbiology Brush
HORIZONS BIOPSY FORCEP
Horizons Papillotome
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)