ARCHEON

Matched from indexed company URL: Archeon

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3017708978	3017708978	ARCHEON	1	N	2026-01-01	2 Chemin des Aiguillettes Besancon Doubs FR 25000

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
316824	1398112464	K221841	EOlife®	BTM	2023-03-18

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
BTM	1	2023-03-18

EOlife Charger - EOlife Charger (ref: A0000029) it the charger of the final device EOlife (AUS00055)
ARCHEON
2023-07-27
EOlife BP - EOlife BP (ref: A0000023) is the Battery Pack including into the final device EOlife (ref: AUS00055)
ARCHEON
2023-07-27
FlowSense - FlowSense (ref: A0000047) is the single use sensor used with EOlife (ref: AUS00055). FlowSense is the consumable of EOlife.FlowSense is sold in boxes of 10 units under the sales reference A0000044.
ARCHEON
2023-07-27
EOlife ECU - EOlife ECU (ref: AUS00004) is the Electronic Control Unit of the EOlife device (ref: AUS00055).
ARCHEON
2023-07-27
EOlife - EOlife device (ref: AUS00055) is the sale reference of final medical device including :- EOlife ECU (ref: AUS00004)- EOlife BP (ref: A0000023)- EOlife Charger (ref: A0000063)- EOlife IFU (ref: AUS00057)
ARCHEON
2023-07-27