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Ena Matrix EMWW

by Micerium SpA

Ref EMWWModel Wooden wedges

Ena Matrix EMWW is a dental wedge (EU MDR Class I; FDA Class I; FDA product code EJB, Handle, Instrument, Dental) made by Micerium SpA, registered in EUDAMED on 3 Jun 2026 (Basic UDI-DI ++EMICFAM1HWO4B) and listed in FDA GUDID since 3 May 2023 (UDI-DI EMICEMWW1), 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
European UnionCE/MDR EUDAMED Number++EMICFAM1HWO4B Basic UDI-DI EMICEMWW1UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICEMWW1 UDI-DI Date3 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++EMICFAM1HWO4B registered 3 Jun 2026 Active
  • FDA GUDID UDI-DI EMICEMWW1 listed 3 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EMICEMWW1
  2. Registered EUDAMED ++EMICFAM1HWO4B

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  • Withdrawn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
Ena Matrix
Generic name
Dental wedge, single-use
Device name
Ena Matrix Wood / Wooden wedges
Model / Ref / Catalog
EMWW, Wooden wedges
Primary DI / UDI-DI
EMICEMWW1
Basic UDI-DI
++EMICFAM1HWO4B
FDA product code
EJB
EMDN code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN term
Dental wedge, single-use
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental wedge, single-use

Similar devices in this category

Other devices filed under PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY.

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)