3d Instrumentation Sdn Bhd

FDA Filings

This page includes the latest FDA filings for 3d Instrumentation Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014170143
FEI Number3014170143
NameMichael van der Woude
Owner & Operator3D Instrumentation Sdn Bhd
Contact AddressNo.95, Lorong IKS Juru 5, Taman Perindus
Bukit Mertajam MY-07 Pulau Pinang 14000 MY
Official Correspondent
  • Lisa Toh
  • 60-4-5040303-x
US Agent
Importing Logistics Registration
ImporterCenCal LLC
Address9228 N Burgan
Clovis, CA 93619 UNITED STATES
Importing Logistics Registration
ImporterDan Darges
Address3654 N Power RD #150
Mesa, AZ 85215 UNITED STATES
Importing Logistics Registration
ImporterMedcom Carolina
Address2228 Page Rd
Durham, NC 27703 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 BEE CAVE ROAD BUILDING 1, SUITE 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Micro Screw (Cannulated)2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
0.6 Single-ended Trocar K-wire 70mm2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Micro Screw (Cannulated)2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
0.6 Single-ended Trocar K-wire 70mm2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Micro Screw Kit Tray and Lid2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Countersink (Cannulated)2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
1.4 FO Micro Drill (Cannulated)2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
1.1 FO Micro Drill2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Micro Depth Gauge (Cannulated)2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Micro Cleaning Stylet2020-01-28
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Surgical Handle, Quick Coupling2019-10-10
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Soft Tissue Protector2019-10-10
Michael van der Woude [3D Instrumentation Sdn Bhd]
FO Micro Hex Driver (Cannulated)2019-10-10
Michael van der Woude [3D Instrumentation Sdn Bhd]
POSITIONER, SOCKET2018-01-19

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