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Ceramic Bracket

by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda 288 variants

Ref 21.02.2002

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

CE MDR

Valid until

Not listed

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

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 Number79084707CERAMICW5 Basic UDI-DI 07908611204080UDI-DIDate21 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07908611204080 UDI-DI Date27 Feb 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Iceram Mini Tubes
Generic Name
Orthodontic tube
Device Name
Ceramic Bracket
Model / Ref / Catalog
21.02.2002
Primary DI / UDI-DI
07908611204080
Basic UDI-DI
79084707CERAMICW5
FDA Product Code
DZD
EMDN Code
Q010403 Orthodontic brackets and buttons
GMDN Term
Orthodontic tube
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.5410
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

Manufacturer details

EUDAMED SRN
BR-MF-000026426
Authorised representative
Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813

Related devices

Category: Orthodontic tube

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

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No