Skip to content

Elastoosas EIE6516

by Micerium SpA

Ref EIE6516Model intra-extra oral latex elastics

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EMICFAM83H Basic UDI-DI EMICEIE65161UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICEIE65161 UDI-DI Date5 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Elastoosas
Generic name
Orthodontic retainer
Device name
Italia intra-extra oral latex elastics / intra-extra oral latex elastics
Model / Ref / Catalog
EIE6516, intra-extra oral latex elastics
Primary DI / UDI-DI
EMICEIE65161
Basic UDI-DI
++EMICFAM83H
FDA product code
KMY
EMDN code
Q010404 Orthodontic elastics, chains and springs
GMDN term
Orthodontic retainer
Device class
Class I
Regulation number
872.5525
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Contains latexEUDAMED
Yes
GUDID
No

Related devices

Category: Orthodontic retainer

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Single use
  • Contains latex YesEUDAMEDNoGUDID
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (20)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No