Rovers Medical Devices B.V.

Contact: Ir. M.D. Zwart
Address: Lekstraat 10, Oss 5347 KV, Netherlands
Phone: +31-(412)-648870 | Fax: +31-(412)-623835 | Map/Directions >>

Profile: Rovers Medical Devices B.V. is engaged in the production of cervical cancer screening, and oral cancer screening products. Our Rovers® cell sampling devices are developed with cell sampling devices with tiny flexible hairs. The mucosal surface is well sampled but not damaged, thus reducing the number of unsatisfactory smears. It can be used for liquid-based cytology(LBC) as well as conventional cytology. Our cervical cancer screening product line comprises of Cervex-Brush® combi, Cervex-Brush®, Endocervex-Brush®, Endocervex-Brush®-S and Viba-brush and Spatula. Our Cervex-Brush® Combi provides doctors & nurses the option of a simultaneous pap smear collection with a single device insertion. Our Endocervex-Brush® is designed to optimize cellular yield in pap smear specimen collection. Our Viba-brush is used to collect cells from the vagina or cervical os. Our Rovers® spatula is intended for the collection of cervical cells for analysis by pap smear methods and by methods for detecting sexually transmitted disease. We also offer preoperative disinfection products that comprises of dry sterile, PVP iodine and chlorhexidine.

The company is ISO 13485:2003 certified.

FDA Registration Number: 9680221
US Agent: Jason Gumaer / Therapak, Llc
Phone: +1-(909)-267-2091  E-Mail:

3 Products/Services (Click for related suppliers)  
• Cytology Cervical Spatula (FDA Code: HHT / 884.4530)
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:
• Ectocervical Cell Sampler
• General & Plastic Surgery Biopsy Brush (FDA Code: GEE / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

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