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Cytobrush Plus C0012

by CooperSurgical, Inc.

Ref C0012Model C0112

Cytobrush Plus C0012 is a cervical cytology brush (EU MDR Class I; FDA Class II; FDA product code HHT, Spatula, Cervical, Cytological) made by CooperSurgical, Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 0888937TD006sYF), cleared under FDA 510(k) K832986 on 10 Feb 1984 and listed in FDA GUDID since 25 Aug 2016 (UDI-DI 00888937003277), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K832986

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888937TD006sYF Basic UDI-DI 00888937003277UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888937003277 UDI-DI Date25 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK832986 Date10 Feb 1984DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0888937TD006sYF registered 27 May 2026 Active
  • FDA 510(k) K832986 decided 10 Feb 1984 Active
  • FDA GUDID UDI-DI 00888937003277 listed 25 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K832986
  2. Listed FDA GUDID 00888937003277
  3. Registered EUDAMED 0888937TD006sYF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Cytobrush® Plus EUDAMED
Cytobrush Plus GUDID
Generic name
Cervical cytology brush
Device name
Cytobrush® Plus GT, Sterile
Model / reference
C0012, C0112
Primary DI / UDI-DI
00888937003277
Basic UDI-DI
0888937TD006sYF
510(k) Number
FDA product code
HHT
EMDN code
W02020502 Cervical screening systems
GMDN term
Cervical cytology brush
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.4530
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cervical cytology brush

Cleared under the same submission (K832986)

and 6 more cleared under K832986

Similar devices in this category

Other devices filed under HISTOLOGY / CYTOLOGY.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)