Skip to content

Parkell® D418

by Parkell, Inc.

Ref D418

Parkell D418 is a particulate water purification filter (EU MDR Class I; FDA Class II; FDA product code ELC, Scaler, Ultrasonic) made by Parkell, Inc., registered in EUDAMED on 17 Nov 2022 (Basic UDI-DI 081000052WATERFILTERC7) and listed in FDA GUDID since 20 Jan 2023 (UDI-DI 00810000522040), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00810000522040 UDI-DI Date20 Jan 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number081000052WATERFILTERC7 Basic UDI-DI 00810000522040UDI-DIDate17 Nov 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081000052WATERFILTERC7 registered 17 Nov 2022 Active
  • FDA GUDID UDI-DI 00810000522040 listed 20 Jan 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 081000052WATERFILTERC7
  2. Listed FDA GUDID 00810000522040

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  • Withdrawn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

Trade name
Parkell®
Generic name
Particulate water purification filter
Model / Ref / Catalog
D418
Primary DI / UDI-DI
00810000522040
Basic UDI-DI
081000052WATERFILTERC7
FDA product code
ELC
EMDN code
Z12119080 Various dental stomatology instruments - hardware accessories
GMDN term
Particulate water purification filter
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.4850
EU registration type
Standard device
EU market of registration
Germany
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: Particulate water purification filter

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Parkell, Inc.

See all devices from Parkell, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)