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Maschera facciale ortodontica

by ITA.O Italian Orthodontic System Srl 10 variants

Ref IT17-001GModel MAXI - MINI

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 Number805267532IT17MASKQ7 Basic UDI-DIDate16 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number08052675320077 UDI-DIDate30 Jun 2021ListedStatusListed 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  • Withdrawn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
Maschera facciale ortodontica EUDAMED
Ita.o GUDID
Generic Name
Orthodontic extraoral headgear
Model / Ref / Catalog
MAXI - MINI, IT17-001G, Maschera facciale ortodontica - MAXI - Giallo
Primary DI / UDI-DI
08052675320077
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
IT17-001G
GUDID
Maschera facciale ortodontica - MAXI - Giallo
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