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T-BASE EASY FIX h9

by Rhein 83 S.r.l.

Ref RMLEF

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08059224208183 UDI-DI Date23 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805804571CSPLL Basic UDI-DI 08059224208183UDI-DIDate18 Mar 2026RegisteredStatusActive

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  • Withdrawn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
T-BASE EASY FIX h9 EUDAMED
TITANIUM EASY FIX T-BASE h9 GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Componenti per Protesi Fissa
Model / Ref / Catalog
RMLEF, 4 EASY FIX T-BASE h4
Primary DI / UDI-DI
08059224208183
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
RMLEF
GUDID
4 EASY FIX T-BASE h4
Device ClassEUDAMED
Class IIb
GUDID
Class I

Manufacturer details

EUDAMED SRN
IT-MF-000005998

From the manufacturer

Manufacturer's product page: Supporto T-Base

Other devices from Rhein 83 S.r.l.

See all devices from Rhein 83 S.r.l. →

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