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Elastics

by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda 291 variants

Ref 60.01.2005

Elastics (60.01.2005) is a device classified as Class IIa in the EU and Class I in the US made by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda, registered in EUDAMED on 19 Mar 2026 (Basic UDI-DI 79084707ELASTICZ8) and listed in FDA GUDID since 28 Sep 2022 (UDI-DI 07908470702079), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number79084707ELASTICZ8 Basic UDI-DI 07908470702079UDI-DIDate19 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07908470702079 UDI-DI Date28 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 79084707ELASTICZ8 registered 19 Mar 2026 Active
  • FDA GUDID UDI-DI 07908470702079 listed 28 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07908470702079
  2. Registered EUDAMED 79084707ELASTICZ8

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  • Withdrawn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
Orthometric Elastomerics - Intra Oral
Generic name
Orthodontic inter-arch elastic band
Device name
Elastics
Model / Ref / Catalog
60.01.2005
Primary DI / UDI-DI
07908470702079
Basic UDI-DI
79084707ELASTICZ8
FDA product code
ECI
EMDN code
Q010404 Orthodontic elastics, chains and springs
GMDN term
Orthodontic inter-arch elastic band
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
EU market of registration
Portugal
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
BR-MF-000026426
Authorised representative
Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813

Related devices

Category: Orthodontic retainer

Similar devices in this category

Other devices filed under ORTHODONTIC ELASTICS, CHAINS AND SPRINGS.

Other devices from Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda

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Properties

  • Single use
  • Contains latex
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)