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Ena Shiny ES6

by Micerium SpA

Ref ES6

Ena Shiny ES6 is a device classified as Class IIa in the EU and Class I in the US made by Micerium SpA, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-EMICES61) and listed in FDA GUDID since 5 May 2023 (UDI-DI EMICES61), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-EMICES61 Basic UDI-DI EMICES61UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICES61 UDI-DI Date5 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EMICES61 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI EMICES61 listed 5 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EMICES61
  2. Registered EUDAMED B-EMICES61

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  • Withdrawn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

Trade name
Ena Shiny
Generic name
Dental mandrel
Device name
Ena/Enamel Plus Shiny
Model / Ref / Catalog
ES6
Description
Ena Shiny Felt Wheels RA Mandrel
Primary DI / UDI-DI
EMICES61
Basic UDI-DI
B-EMICES61
FDA product code
EJB
EMDN code
Q01010403 Dental abrasive and polishing materials
GMDN term
Dental mandrel
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI EMICES61: EUDAMED states Yes, FDA GUDID states No.

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.

Related devices

Category: Dental mandrel

Similar devices in this category

Other devices filed under DENTAL ABRASIVE AND POLISHING MATERIALS.

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)