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Ot Equator Insertion/Extraction Tool

by Rhein 83 S.r.l. 2 variants

Part of a family of 108 devices: see the family page

Ref ET-IT002A

Ot Equator Insertion/Extraction Tool (ET-IT002A) is a Class I device made by Rhein 83 S.r.l., registered in EUDAMED on 24 Jan 2025 (Basic UDI-DI 805804571STRPB), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805804571STRPB Basic UDI-DI 08059224133157UDI-DIDate24 Jan 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Strumenti (Regola 1)
Model / reference
ET-IT002A
Primary DI / UDI-DI
08059224133157
Basic UDI-DI
805804571STRPB
EMDN code
Q010280 Prosthetic dentistry devices - accessories
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

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
Other properties (13, all answered No)