Apelem

FDA Filings

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

FDA Registration(s)
Registration Number9616491
FEI Number3000255482
NameAPELEM
Owner & OperatorApelem
Contact AddressParc Scientifique Georges Besse 175 allee Von Neumann
Nimes FR-K Languedoc-Roussillon 30035 FR
Official Correspondent
  • Laure LANDUCCI
  • 33-4-66291039-x
US Agent
Importing Logistics Registration
ImporterViztek
Address2217 US Highway 70 East
Garner, NC 27529 UNITED STATES
Email Addressbashby@viztek.net
Phone1 919 7926420
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressParc Scientifique Georges Besse 175 allee Von Neumann
Nimes Languedoc-Roussillon, 30035 FR
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
APELEM
APELEM 2023-06-15
APELEM
APELEM 2023-06-15
APELEM
APELEM 2023-06-15
APELEM
APELEM 2023-06-15
APELEM
APELEM 2023-06-08
APELEM
APELEM 2022-04-20
APELEM
Platinum dRF - version with RF4343FL2016-12-15
APELEM
PLATINUM dRF2014-08-01

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Related Finance Registrations
NCAGE CodeFAFE3APELEM
CAGE CodeFAFE3APELEM

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