Alex Atmadi

FDA Filings

This page includes the latest FDA filings for Alex Atmadi. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3015332747
FEI Number3015332747
NameAlex Atmadi
Owner & OperatorPT Esco Bintan Indonesia
Contact AddressJL Asoka Bock D6-D10 Bintan Industrial E
Tanjung Uban ID-KR Kepulauan Riau 29154 ID
Official Correspondent
  • Jennyfel B Brillantes
  • 62-0770-696033-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address903 Sheehy Drive, Suit F, Horsham
Horsham, PA 19044 US
Establishment TypeManufacture Medical Device



Registration Number3015542892
FEI Number3015542892
NameAlex Atmadi
Owner & OperatorEsco Aster Pte. Ltd.
Contact Address71 Ayer Rajah Crescent #03-20
Singapore SG-01 Central Singapore 139951 SG
Official Correspondent
  • Xiangliang Lin
  • 65-625-19361-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address903 Sheehy Drive, Suit F
Horsham, PA 19044 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Alex Atmadi [Esco Aster Pte. Ltd.]
TideXcell Cell Harvesting System2019-07-10
Alex Atmadi [Esco Aster Pte. Ltd.]
TideXcell Bioreactor2019-07-10
Alex Atmadi [Esco Aster Pte. Ltd.]
CelCradle-XSA Bioreactor2019-07-10
Alex Atmadi [Esco Aster Pte. Ltd.]
CelCradle-XFA Bioreactor2019-07-10
Alex Atmadi [Esco Aster Pte. Ltd.]
CelCradle-X Bioreactor2019-07-10
Alex Atmadi [Esco Aster Pte. Ltd.]
CelCradle Mini Harvesting System2019-07-10
Alex Atmadi [Esco Aster Pte. Ltd.]
CelCradle Bioreactor2019-07-10
Alex Atmadi [PT Esco Bintan Indonesia]
Esco Celmate CO2 Incubator2019-04-03
Alex Atmadi [PT Esco Bintan Indonesia]
Esco CelCulture CO2 Incubator2019-04-03

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