Data / Medical devices / United States / NC - Albaad Fem US

NC - Albaad Fem US: FDA-registered device maker in Kernersville, NC, United States, 12 510(k) clearances

Name: NC - Albaad Fem US FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

NC - Albaad Fem US is registered with the FDA (registration 3014833751) in Kernersville, NC, United States. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 3, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014833751
Address: 1615 Piedmont Commerce Dr, Kernersville, NC, United States, 27284
Owner or operator: Albaad Fem US (1526071)
Roles: Repackager or relabeler
First device listed: May 8, 2016
Registered through: 2026
Brand names listed: Interlude Rolled Tampons in Plastic Applicator, Interlude or other private label names

Devices it lists

Device	Product code	Class	Role	Source
Tampon, Menstrual, Scented, Scented-Deodorized	HIL	2	Repackager or relabeler	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Repackager or relabeler	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
August 3, 2023	K230419	Sequel Tampon with Plastic Applicator	HEB	Substantially Equivalent	Tampro, Inc.	accessdata.fda.gov
October 7, 2019	K191431	Interlude Rolled Tampons in Plastic Applicator	HEB	Substantially Equivalent	Albaad Fem	accessdata.fda.gov
November 2, 2018	K181911	Interlude 100% Cotton Tampon	HEB	Substantially Equivalent	Albaad Fem	accessdata.fda.gov
June 15, 2018	K173225	Interlude and private label Unscented 3-piece compact applicator tampon	HEB	Substantially Equivalent	Albaad Fem	accessdata.fda.gov
September 22, 2014	K140077	ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED	HEB	Substantially Equivalent	Albaad , Ltd.	accessdata.fda.gov
May 28, 2009	K090071	ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS	HEB	Substantially Equivalent	Rostam , Ltd.	accessdata.fda.gov
December 7, 2006	K062001	ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS	HEB	Substantially Equivalent	Rostam , Ltd.	accessdata.fda.gov
November 23, 2004	K042773	ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS	HIL	Substantially Equivalent	Rostam , Ltd.	accessdata.fda.gov
May 28, 2004	K030474	PH BUFFERING PLASTIC APPLICATOR TAMPON	HEB	Substantially Equivalent	Rostam , Ltd.	accessdata.fda.gov
May 9, 2002	K020535	INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS	HEB	Substantially Equivalent	Rostam , Ltd.	accessdata.fda.gov
August 3, 2000	K001641	TAMPONS	HEB	Substantially Equivalent	Rostam , Ltd.	accessdata.fda.gov
February 20, 1997	K965064	ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON	HEB	Substantially Equivalent	Rostam , Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 3, 2023. 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.