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ROVERS MEDICAL DEVICES BV

Netherlands · Oss

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 2Class II 1Class III 0

plus 7 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 9

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 3 510(k), 0 PMA, 2 excluded

Brazil9 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: ROVERS MEDICAL DEVICES B.V. · ROVERS MEDICAL DEVICES BV · Rovers Medical Devices B.V.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K043369	CERVEX-BRUSH COMBI	2005-02-02
US	K002520	ROVERS SPATULA	2000-11-13
US	K001119	ROVERS ENDOCERVEX-BRUSH	2000-05-19
BR	10287411802	Evalyn® Brush	Class I
BR	10033430642	BD Escovas para coleta de amostras cervicais estéreis	Class I
BR	10033430643	Rovers Orcellex Brush - Rovers Escova Oral	Class I
SA	ME0000001379SFDAA00001	Rovers Cervical Brush	—

ROVERS MEDICAL DEVICES BV

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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