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Rovers Medical Devices B.V.: FDA-registered device maker in OSS Noord-Brabant, Netherlands, 5 510(k) clearances

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

Rovers Medical Devices B.V. is registered with the FDA (registration 9680221) in OSS Noord-Brabant, Netherlands. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 2, 2005. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9680221
FEI number: 1000183403
Address: Lekstraat 10, OSS Noord-Brabant, Netherlands, 5347 KV
Owner or operator: ROVERS MEDICAL DEVICES B.V. (9007299)
Roles: Manufacturer
First device listed: August 14, 2007
Registered through: 2026
Brand names listed: Rovers Anex Brush, Rovers Cervex-Brush, Rovers Cervex-Brush Combi, Rovers EndoCervex-Brush, Rovers EndoCervex-Brush-S, Rovers Evalyn Brush, Rovers Orcellex-Brush, Rovers Orcellex-Brush RT and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Brush, Biopsy, General & Plastic Surgery	GEE	1	Manufacturer	accessdata.fda.gov
Spatula, Cervical, Cytological	HHT	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
February 2, 2005	K043369	CERVEX-BRUSH COMBI	HHT	Substantially Equivalent	Rovers Medical Devices B.V.	accessdata.fda.gov
November 13, 2000	K002520	ROVERS SPATULA	HHT	Substantially Equivalent	Rovers Medical Devices B.V.	accessdata.fda.gov
May 19, 2000	K001119	ROVERS ENDOCERVEX-BRUSH	HHT	Substantially Equivalent	Rovers Medical Devices B.V.	accessdata.fda.gov
January 5, 1995	K933870	VIBA-BRUSH	HHT	Substantially Equivalent	Rovers B.V.	accessdata.fda.gov
May 24, 1994	K930955	CERVEX-BRUSH	HHT	Substantially Equivalent	Rovers B.V.	accessdata.fda.gov

Compare with other makers

Updated February 2, 2005. 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.