Skip to content

Eq-S

by Meta Systems Co., Ltd. 5 variants

Ref 126-250Model EQ-S

Eq-S (126-250) is a root canal irrigation handpiece (EU MDD Class IIa; FDA Class I; FDA product code JET, Pick, Massaging) made by Meta Systems Co., Ltd., registered in EUDAMED on 1 Apr 2026 (Basic UDI-DI B-08809455600597) and listed in FDA GUDID since 2 Mar 2020 (UDI-DI 08809455600597), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809455600597 Basic UDI-DI 08809455600597UDI-DIDate1 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809455600597 UDI-DI Date2 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809455600597 registered 1 Apr 2026 Active
  • FDA GUDID UDI-DI 08809455600597 listed 2 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809455600597
  2. Registered EUDAMED B-08809455600597

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Root canal irrigation handpiece
Device name
Sonic Powered Endo Irrigation
Model / reference
EQ-S, 126-250
Primary DI / UDI-DI
08809455600597
Basic UDI-DI
B-08809455600597
FDA product code
JET
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Root canal irrigation handpiece
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6650
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
KR-MF-000022945
Authorised representative
Meta Biomed Europe GmbH DE-AR-000004953

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Meta Systems Co., Ltd.

See all devices from Meta Systems Co., Ltd. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
Other properties (20, all answered No)