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Maschera facciale ortodontica

by ITA.O Italian Orthodontic System Srl EUDAMEDGUDID 10 variants

Active European Union

Ref IT17-002RModel MAXI - MINI

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805267532IT17MASKQ7 Basic UDI-DIDate16 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number08052675320039 UDI-DIDate30 Jun 2021ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Maschera facciale ortodontica EUDAMED
Ita.o GUDID
Generic Name
Orthodontic extraoral headgear
Model / Ref / Catalog
MAXI - MINI, IT17-002R, Maschera facciale ortodontica - MINI - Rosso
Primary DI / UDI-DI
08052675320039
Basic UDI-DI
805267532IT17MASKQ7
510(k) Number
FDA Product Code
DZB
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic extraoral headgear
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.5500
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MAXI - MINI
IT17-002R
GUDID
Maschera facciale ortodontica - MINI - Rosso
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000009970

Other devices from ITA.O Italian Orthodontic System Srl

See all devices from ITA.O Italian Orthodontic System Srl →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No