Data / Medical devices / Tunisia / Bieffe Medital Manufacturing Oued Ellil Tunisia

Bieffe Medital Manufacturing Oued Ellil Tunisia: FDA-registered device maker in Oued Ellil Manouba, Tunisia, 4 510(k) clearances

Name: Bieffe Medital Manufacturing Oued Ellil Tunisia FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bieffe Medital Manufacturing Oued Ellil Tunisia is registered with the FDA (registration 3006755813) in Oued Ellil Manouba, Tunisia. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 10, 2021. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3006755813
Address: Route de chebbaou, Oued Ellil Manouba, Tunisia, 2021
Owner or operator: Vantive US Healthcare LLC (9038727)
Roles: Manufacturer
First device listed: April 14, 1998
Registered through: 2026
Brand names listed: AK 98 Dialysis Machine, Automated PD Set with Cassette 4-Prong, C-705 Accessory Expansion Chamber, Gambro Bloodlines, HomeChoice PRO Automated Personal Cycler, Homechoice, Hospal Bloodlines, Integrated APD Set with Cassette 3-prong and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Blood Circuit, Hemodialysis	KOC	2	Manufacturer	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Manufacturer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Manufacturer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Manufacturer	accessdata.fda.gov
System, Peritoneal, Automatic Delivery	FKX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 10, 2021	K201809	AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory	KDI	Substantially Equivalent	Baxter Healthcare Corportation	accessdata.fda.gov
March 30, 2011	K102936	HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R	FKX	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
January 5, 1983	K823707	HOSPAL BLOOD LINES	KOC	Substantially Equivalent	Hospal Medical Corp.	accessdata.fda.gov
May 30, 1980	K801016	GAMBRO G SERIES BLOOD LINE SETS FOR HEM.	FJK	Substantially Equivalent	Gambro, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 10, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.