Rovers® Cervex-Brush® Combi

FDA UDI

Class II (US FDA UDI)

by Rovers Medical Devices B.V.

Identity

Trade Name: Rovers® Cervex-Brush® Combi FDA UDI
Generic Name: Cytology scraper, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 380102031 FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 18719189246084 FDA UDI
510(k) Number: K043369 FDA UDI
FDA Product Code: HHT FDA UDI
GMDN Term: Cytology scraper, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cytology scraper, single-use

Rovers® Cervex-Brush® Combi by Rovers Medical Devices B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cytology scraper, single-use.

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EsoCheck CCD Cell Collection Device — LUCID DIAGNOSTICS, INC. · Class II
LabChoice Cell Scraper, Sterile, 25 cm — Dynarex Corp. · Class I
Puritan Histobrush — PURITAN MEDICAL PRODUCTS COMPANY LLC · Class II

Cleared under the same submission

K043369 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Rovers Medical Devices B.V.

Sources (1)

FDA UDI 2b74124a-92ef-455f-b4e4-0cc29f050542 34 fields · synced May 30, 2026