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Guaina Calcinabile Easy Fix H.4

by Rhein 83 S.r.l.

Ref 240GCEF

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 Number805804571CLCK5 Basic UDI-DI 08059224205533UDI-DIDate17 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224205533 UDI-DI Date30 Apr 2025ListedStatusListed 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  • Withdrawn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
Guaina Calcinabile Easy Fix H.4 EUDAMED
Ot Equator GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Calcinabili
Model / Ref / Catalog
240GCEF, HIGH CASTABLE SLEEVE EASY FIX
Primary DI / UDI-DI
08059224205533
Basic UDI-DI
805804571CLCK5
FDA Product Code
EJX
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class I
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
240GCEF
GUDID
HIGH CASTABLE SLEEVE EASY FIX
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000005998

From the manufacturer

Manufacturer's product page: EASY FIX

Other devices from Rhein 83 S.r.l.

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

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • 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