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OT EQUATOR SET OT EQUATOR C1 STD MIS h3 +S.BOX

by Rhein 83 SRL EUDAMEDGUDID

Active European Union

Ref 131C1S3

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08059224140179 UDI-DIDate23 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805804571ADTK5 Basic UDI-DIDate18 Mar 2026RegisteredStatusActive

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  • Withdrawn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

1 certificate · EUDAMED

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

    Quality management system EU MDR

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
OT EQUATOR C1 Std MIS h.3 c/SmartBox EUDAMED
Ot Equator GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Attacchi Diretti in Titanio
Model / Ref / Catalog
131C1S3, SET OT EQUATOR C1 STD MIS h3 +S.BOX
Primary DI / UDI-DI
08059224140179
Basic UDI-DI
805804571ADTK5
FDA Product Code
NHA
EMDN Code
Q010299 Prosthetic dentistry devices - other
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
131C1S3
GUDID
SET OT EQUATOR C1 STD MIS h3 +S.BOX
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Rhein 83 SRL

See all devices from Rhein 83 SRL →

Properties

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

Other properties (19)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No