FDA Registration
Active
🇨🇷 Costa Rica
ITEK
Reg #: 3014263632
·
FEI: 3014263632
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- ITEK
- Registration Number
- 3014263632
- FEI Number
- 3014263632
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zona Franca La Lima, Edificio MT4
- City
- Cartago
- Country
- CR
Owner / Operator
- Firm Name
- ITEK
- Operator Number
- 10087095
- Address
- Zona Franca La Lima, Edificio MT4
- City
- Cartago
- State
- CR-C
- Postal Code
- 30106
- Country
- CR
- Correspondent
- Bernal Rodriguez
US Agent
- Business Name
- DD Global MedDev Consulting
- Contact Name
- Donna Djinovich
- Address
- 501 N Clinton St Apt 907
- City
- Chicago
- State
- IL
- ZIP
- 60654
- Country
- US
- [email protected]
- Phone
- 847 9035920
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2024-04-08 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-04-08 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-07-14 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-08-28 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2025-07-01 |
Proprietary Names
Celsi Monitor
DANNIK Specimen Retrieval System
Navi Needle-free Blood Collection Device
Celsi Warmer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)