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Parkell®

by Parkell Inc. 31 variants

Ref S379

Parkell® (S379) is a Class I device made by Parkell, Inc., registered in EUDAMED on 17 Nov 2022 (Basic UDI-DI 081000052APPBRUSH84) and listed in FDA GUDID since 16 Aug 2019 (UDI-DI 10810000527561), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081000052APPBRUSH84 Basic UDI-DI 10810000527561UDI-DIDate17 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10810000527561 UDI-DI Date16 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081000052APPBRUSH84 registered 17 Nov 2022 Active
  • FDA GUDID UDI-DI 10810000527561 listed 16 Aug 2019 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 10810000527561
  2. Registered EUDAMED 081000052APPBRUSH84

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Dental material application tool, single-use
Device name
Applicator Brush
Model / Ref / Catalog
S379
Primary DI / UDI-DI
10810000527561
Basic UDI-DI
081000052APPBRUSH84
Unit of use DI
00810000527564
FDA product code
KXF
EMDN code
Q019006 Dental material application tips and brushes, single-use
GMDN term
Dental material application tool, single-use
Device class
Class I
Regulation number
880.6025
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000003761
Authorised representative
Directa AB SE-AR-000002492

Related devices

Category: Dental material injection cannula, single-use

Similar devices in this category

Other devices filed under DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE.

Other devices from Parkell, Inc.

See all devices from Parkell, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)