Rovers® EndoCervex-Brush®

FDA UDIEUDAMED

Class II (US FDA UDI)

by Rovers Medical Devices B.V.

Identity

Trade Name: Rovers® EndoCervex-Brush® FDA UDI
Generic Name: Cytology scraper, single-use FDA UDI
Device Name: EndoCervical cell sampler FDA UDI
Model / Reference: 380100703 FDA UDI
Description: EndoCervical cell sampler FDA UDI

Identifiers

Primary DI / UDI-DI: 87191892461006 FDA UDI
510(k) Number: K001119 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Rovers® EndoCervex-Brush® by Rovers Medical Devices B.V. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K001119 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
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 (2)

FDA UDI 454bdc03-495f-48c8-99b9-330915aa58c4 36 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 2, 2026