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Kit Accessori Monouso Tt Transformer

by TT Tooth Transformer srl

Ref TT8002Model KIT ACCESSORI MONOUSO TT TRANSFORMER

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, 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 Number80557285800000000TT800235 Basic UDI-DI 08055728580015UDI-DIDate3 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08055728580015 UDI-DI Date29 Jun 2022ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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

Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
KIT ACCESSORI MONOUSO TT TRANSFORMER, TT8002, 01
Primary DI / UDI-DI
08055728580015
Basic UDI-DI
80557285800000000TT800235
FDA Product Code
GEY
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Dental/maxillofacial surgical procedure kit, non-medicated, single-use
Device Class
Class I
Regulation Number
878.4820
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
KIT ACCESSORI MONOUSO TT TRANSFORMER
TT8002
GUDID
01

Manufacturer details

EUDAMED SRN
IT-MF-000027253

Other devices from Tt Tooth Transformer SRL

Properties

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

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No