ROVERS MEDICAL DEVICES B.V.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9680221	1000183403	ROVERS MEDICAL DEVICES B.V.	1	N	2027-01-01	LEKSTRAAT 10 OSS Noord-Brabant NL 5347 KV

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
46787	1451913477	K933870	VIBA-BRUSH	HHT	1995-01-05
46787	1800519324	K930955	CERVEX-BRUSH	HHT	1994-05-24
46787	1280588585	K043369	CERVEX-BRUSH COMBI	HHT	2005-02-02
46787	1173582978	K002520	ROVERS SPATULA	HHT	2000-11-13
46787	1754735270	K001119	ROVERS ENDOCERVEX-BRUSH	HHT	2000-05-19
46787	1570759989
46787	1679310178

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HHT	5	2005-02-02

PMN#

CERVEX-BRUSH COMBI
2005-02-02
ROVERS MEDICAL DEVICES B.V.
ROVERS SPATULA
2000-11-13
ROVERS MEDICAL DEVICES B.V.
ROVERS ENDOCERVEX-BRUSH
2000-05-19
ROVERS MEDICAL DEVICES B.V.

GUDID#

Rovers® Anex® Brush - The Anex® Brush is a single-use cell sampler intended to collect cells from the anal canal.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® Combi - The Cervex-Brush® Combi is a single-use cell sampler intended to collect simultaneous cell material from the ectocervical, endocervical and transformation-zone in women.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Viba-Brush® - The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Viba-Brush® - The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Viba-Brush® - The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® - The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material from the cervical os, ectocervical and endo-cervical in women.
Rovers Medical Devices B.V.
2023-07-12
Rovers® EndoCervex-Brush® - The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.
Rovers Medical Devices B.V.
2023-07-12
Rovers® EndoCervex-Brush® - The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.
Rovers Medical Devices B.V.
2023-07-12
Rovers® EndoCervex-Brush®-S - The EndoCervex-Brush®-S is a single-use cell sampler Intended to collect endocervical cells in women.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® - The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material from the cervical os, ectocervical and endo cervical canal in women.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® Combi - 380301031
Rovers Medical Devices B.V.
2023-07-12
Rovers® Evalyn® Brush - The Evalyn® Brush Is a single use (self) cell-sampler device that allows easy, painless, safe and effective collection of cell material from the vagina.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Anex® Brush - The Anex® Brush is a single-use cell sampler intended to collect cells from the anal canal.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® Combi - The Cervex-Brush® Combi is a single-use cell sampler intended to collect simultaneous cell material from the ectocervical, endocervical and transformation-zone in women.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Viba-Brush® - The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Viba-Brush® - The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Viba-Brush® - The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® - The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material from the cervical os, ectocervical and endo-cervical in women.
Rovers Medical Devices B.V.
2023-07-12
Rovers® EndoCervex-Brush® - The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.
Rovers Medical Devices B.V.
2023-07-12
Rovers® EndoCervex-Brush® - The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.
Rovers Medical Devices B.V.
2023-07-12
Rovers® EndoCervex-Brush®-S - The EndoCervex-Brush®-S is a single-use cell sampler Intended to collect endocervical cells in women.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® - The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material from the cervical os, ectocervical and endo cervical canal in women.
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® Combi - 380301031
Rovers Medical Devices B.V.
2023-07-12
Rovers® Cervex-Brush® - Cervical cell sampler
Rovers Medical Devices B.V.
2017-10-20
Rovers® Cervex-Brush® - Cervical cell sampler
Rovers Medical Devices B.V.
2017-10-20
Rovers® Cervex-Brush® - Cervical cell sampler, sterile
Rovers Medical Devices B.V.
2017-10-19
Rovers® Cervex-Brush® Combi - Cervical cell sampler
Rovers Medical Devices B.V.
2018-07-16
Rovers® EndoCervex-Brush® -S - EndoCervical cell sampler
Rovers Medical Devices B.V.
2018-07-16
Rovers® Cervex-Brush® Combi - Cervical cell sampler, sterile
Rovers Medical Devices B.V.
2017-10-19
Rovers® Orcellex® Brush RT - Oral cell sampler, sterile
Rovers Medical Devices B.V.
2017-10-22
Rovers® Cervex-Brush® Combi RT - Cervical cell sampler
Rovers Medical Devices B.V.
2018-07-16
Rovers® Cervex-Brush® RT - Cervical cell sampler
Rovers Medical Devices B.V.
2018-07-16
Rovers® EndoCervex-Brush®-S RT - EndoCervical cell sampler, sterile
Rovers Medical Devices B.V.
2017-10-19
Rovers® Evalyn® Brush - Vaginal cell sampler, sterile
Rovers Medical Devices B.V.
2019-12-11
Rovers® Cervex-Brush® RT - Cervical cell sampler
Rovers Medical Devices B.V.
2017-10-20
Rovers® Cervex-Brush® Combi - Cervical cell sampler, sterile
Rovers Medical Devices B.V.
2017-10-20
Rovers® Cervex-Brush® RT - Cervical cell sampler
Rovers Medical Devices B.V.
2017-10-20
Rovers® Cervex-Brush® Combi - Cervical cell sampler
Rovers Medical Devices B.V.
2019-09-11
Rovers® Cervex-Brush® - Cervical cell sampler
Rovers Medical Devices B.V.
2019-09-11
Rovers® Cervex-Brush® - Cervical cell sampler
Rovers Medical Devices B.V.
2018-07-09

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