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
Phone
714 3307454

Products

Device Name Product Code
Syringe, Piston FMF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Accessories, Catheter KGZ
Laparoscope, General & Plastic Surgery GCJ
Cannula, Surgical, General & Plastic Surgery GEA
Syringe, Irrigating (Non Dental) KYZ
Regulator, Pressure, Gas Cylinder CAN

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