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OT EQUATOR-EASY FIX KIT EASY FIX T-BASE h.6

by Rhein 83 SRL

Ref KMASRF

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

CE MDR

Valid until

2 Dec 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805804571CSPLL Basic UDI-DI 08059224207810UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224207810 UDI-DI Date10 Feb 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030107-02 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    21 Jan 2026
    Expires
    2 Dec 2029

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  • Withdrawn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
EASY FIX T-BASE h6 EUDAMED
Ot Equator-Easy Fix GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Componenti per Protesi Fissa
Model / Ref / Catalog
KMASRF, KIT EASY FIX T-BASE h.6
Primary DI / UDI-DI
08059224207810
Basic UDI-DI
805804571CSPLL
FDA Product Code
EJX
EMDN Code
Q010299 Prosthetic dentistry devices - other
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
872.3130
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
KMASRF
GUDID
KIT EASY FIX T-BASE h.6
Device ClassEUDAMED
Class IIb
GUDID
Class I

Other devices from Rhein 83 SRL

See all devices from Rhein 83 SRL →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No