FDA Registration
Active
🇨🇷 Costa Rica
BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A.
Reg #: 3027242374
·
FEI: 3027242374
·
Expires 2026
Products
25
Proprietary Names
11
Establishment Types
1
Classifications
25
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Registration Details
- Registration Name
- BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A.
- Registration Number
- 3027242374
- FEI Number
- 3027242374
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Oficentro Don Hugo Local #1, 250 este del Centro Comercial Plaza Mayor
- City
- Rohrmoser San Jose
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K202581
Owner / Operator
- Firm Name
- Biotec Biotecnologias de Centroamerica S.A.
- Operator Number
- 10087853
- Address
- Oficentro Don Hugo Local #1, 250 este del Centro Comercial Plaza Mayor
- City
- Rohrmoser
- State
- San Jose
- Postal Code
- 10109
- Country
- CR
US Agent
- Business Name
- Arthrex Inc
- Contact Name
- Barry Dietz
- Address
- 1370 Creekside Blvd
- City
- Naples
- State
- FL
- ZIP
- 34108
- Country
- US
- [email protected]
- Phone
- 800 9337001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2023-04-20 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-04-20 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2023-04-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-04-20 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-04-20 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-04-20 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-04-20 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2025-07-24 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-04-20 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2023-04-20 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2023-04-20 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2023-04-20 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-04-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-07-24 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2023-04-20 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2023-04-20 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-07-24 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-07-24 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2023-04-20 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2025-07-24 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2023-04-20 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2023-04-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-04-20 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2025-07-24 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2023-04-20 |
Proprietary Names
CLAMP
AIR SAFETY HEPA AND NON-HEPA FILTERS
GAUGE, DEPTH
FORCEPS
MINI TIGHTROPE
MICROSUTURE ANCHORS
CAMERA, SURGICAL AND ACCESSORIES
Insufflator 50L FM134
CMC MINI TIGHTROPE
Accessories, arthroscopic
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device