Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680221

FEI Number

1000183403

Entity Name

ROVERS MEDICAL DEVICES B.V.

City/State/Country

OSS Noord-Brabant, NL

Establishment Address

LEKSTRAAT 10, OSS Noord-Brabant 5347 KV, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ROVERS MEDICAL DEVICES B.V. (Owner Number: 9007299)

Owner / Operator Contact Address

LEKSTRAAT 10, --, OSS, NL-NOTA 5347 KV, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rovers Anex Brush Rovers Evalyn Brush Rovers Viba-Brush Rovers Viba-Brush RT Rovers Viba-Brush Rovers Spatula Rovers® Cervex-Brush® RT Rovers Cervex-Brush Rovers Orcellex-Brush RT Rovers Orcellex-Brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2014-10-29
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2008-02-13
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2008-02-13
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2008-02-13
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

ROVERS MEDICAL DEVICES B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963801	Young OU Brush Co.	PAP BRUSH	1997-04-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680221. Last updated year: 2026. Please use registration number 9680221 when referencing this establishment in official correspondence.