FDA Registration
Active
🇲🇽 Mexico
Nordson MEDICAL Mexico
Reg #: 3005448067
·
FEI: 3005448067
·
Expires 2026
Products
7
Proprietary Names
36
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Nordson MEDICAL Mexico
- Registration Number
- 3005448067
- FEI Number
- 3005448067
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carretera Internacional KM 129, Salida Norte, Sin Numero Parque Industrial, Roca Fuerte
- City
- Guaymas Sonora
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K012868
Owner / Operator
- Firm Name
- Nordson MEDICAL (CA), LLC
- Operator Number
- 10027667
- Address
- 7612 Woodwind Drive
- City
- Huntington Beach
- State
- CA
- Postal Code
- 92647
- Country
- US
- Correspondent
- Ben Do
US Agent
- Business Name
- Nordson Medical (CA), LLC
- Contact Name
- Ben Do
- Address
- 7612 woodwind drive
- City
- Huntingtn Bch
- State
- CA
- ZIP
- 92647
- Country
- US
- [email protected]
- Phone
- 714 3307454
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2016-03-22 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2019-11-05 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2016-03-22 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-03-22 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2024-12-06 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2016-03-22 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2016-03-22 |
Proprietary Names
FibriJet Topical Gas Assisted Applicator Tip
FibriJet Gas Assisted Applicator Kit
FibriJet Applicator Tip Dual Cannula
ProtekSolo Transseptal (72 FR)
FibriJet Endoscopic Catheter Introducer
Applicator Tip, Malleable
FibriJet Pole Clamp
Graft Delivery Device
Malleable Tip Applicators, Pramand Applicator Tip, Flexure Applicator Tip
Graft Delivery, DePuy Synthes
FibriJet Graft Delivery Device
FibriJet OsteoPrecision Graft Delivery Device
FibriJet Applicator Tips Dual Cannula, Malleable
FibriJet Mixing Applicator Tips
FibriJet Single Cannula Extended Applicators
FibriJet Applicator Tip, Dual Channel Flexible Catheter
FibriJet Single Chanel Mixing Applicators
FibriJet Dual Spray Procedure Kit
FibriJet Blending Connectors
FibriJet Applicator Tip Single Spray
FibriJet Applicators with Dual Spray
FibriJet Applicator Assemblies
FibriJet Applicator Tips Dual Cannula
FibriJet Dual Spray Applicator Tip
Endoscopic Applicator (0600225)
Edwards Lifesciences Venous Drainage Cannulae
Endoscopic Applicator (0600125)
ProtekDuo Dual-Lumen (31 FR)
ProtekSolo Transseptal
FibriJet Applicator Tip Dual Lumen Cannula
FibriJet 360 Endoscopic Applicator
FibriJet Spray Set Endoscopic Applicator
FibriJet Gas Assisted Endoscopic Applicator Spray Set
FibriJet Endoscopic Applicator with Mixing Tip
Control Unit Regulator
FibriJet Regulators
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device