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G. Calcinabile per Mtsfeg/Rmtsfeg #1

by Rhein 83 S.r.l.

Ref GCMR

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 Number805804571CLCK5 Basic UDI-DI 08059224130224UDI-DIDate17 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224130224 UDI-DI Date21 Oct 2020ListedStatusListed 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  • Withdrawn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

Trade Name
G. Calcinabile per Mtsfeg/Rmtsfeg #1 EUDAMED
Ot Equator-Ot Bridge GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Device Name
Calcinabili
Model / Ref / Catalog
GCMR, CASTABLE SLEEVE Ø3, 5-4 FOR INCLINED AB. 1 u.
Primary DI / UDI-DI
08059224130224
Basic UDI-DI
805804571CLCK5
FDA Product Code
NDP
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
GCMR
GUDID
CASTABLE SLEEVE Ø3,5-4 FOR INCLINED AB. 1 u.
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000005998

Other devices from Rhein 83 S.r.l.

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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