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REAMER x REGULATING CAPS STANDARD size

by Rhein 83 S.r.l. EUDAMEDGUDID

Active European Union

Ref 080RCNB

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805804571STRPB Basic UDI-DIDate24 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224039053 UDI-DIDate30 Jul 2021ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
REAMER x REGULATING CAPS STANDARD size EUDAMED
Dental Attachments GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Strumenti (Regola 1)
Model / Ref / Catalog
080RCNB, REAMER x REGULATING CAPS STANDARD size
Primary DI / UDI-DI
08059224039053
Basic UDI-DI
805804571STRPB
FDA Product Code
NDP
EMDN Code
Q010280 Prosthetic dentistry devices - accessories
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class I
Regulation Number
872.3980
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
080RCNB
GUDID
REAMER x REGULATING CAPS STANDARD size
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000005998

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