Data / Medical devices / Netherlands / WCPH B.V.

WCPH B.V.: FDA-registered device maker in Leiden Zuid-Holland, Netherlands, 2 510(k) clearances

Name: WCPH B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

WCPH B.V. is registered with the FDA (registration 3012934891) in Leiden Zuid-Holland, Netherlands. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 2, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012934891
Address: Admiraal Banckertweg 12, Leiden Zuid-Holland, Netherlands, 2315 SR
Owner or operator: WCPH B.V. (10073089)
Roles: Repackager or relabeler
First device listed: May 6, 2020
Registered through: 2026
Brand names listed: Always, Diaper, Nappy, Oral B

Devices it lists

Device	Product code	Class	Role	Source
Garment, Protective, For Incontinence	EYQ	1	Repackager or relabeler	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Repackager or relabeler	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	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
June 2, 2011	K110669	TAMPAX C PLASTIC TAMPONS, UNSCENTED	HEB	Substantially Equivalent	The Procter & Gamble Co.	accessdata.fda.gov
June 5, 2006	K061351	ORAL-B SONIC COMPLETE	JEQ	Substantially Equivalent	Braun GmbH	accessdata.fda.gov

Compare with other makers

Updated June 2, 2011. 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.