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Accessori

by Rhein 83 S.r.l.

Ref 761OTL

Accessori (761OTL) is a Class I device made by Rhein 83 S.r.l., registered in EUDAMED on 5 May 2026 (Basic UDI-DI 805804571ACCHY) and listed in FDA GUDID since 10 Feb 2026 (UDI-DI 08059224187099), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805804571ACCHY Basic UDI-DI 08059224187099UDI-DIDate5 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224187099 UDI-DI Date10 Feb 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805804571ACCHY registered 5 May 2026 Active
  • FDA GUDID UDI-DI 08059224187099 listed 10 Feb 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08059224187099
  2. Registered EUDAMED 805804571ACCHY

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  • Withdrawn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
Instruments
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Accessori
Model / Ref / Catalog
761OTL, OT LEVER
Primary DI / UDI-DI
08059224187099
Basic UDI-DI
805804571ACCHY
FDA product code
NDP
EMDN code
Q010280 Prosthetic dentistry devices - accessories
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
761OTL
GUDID
OT LEVER

Manufacturer details

EUDAMED SRN
IT-MF-000005998

Similar devices in this category

Other devices filed under PROSTHETIC DENTISTRY DEVICES - ACCESSORIES.

Other devices from Rhein 83 S.r.l.

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

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)