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Sm Tube

by Osstem Orthodontics Inc. 95 variants

Ref 511-27-10Model SM TUBE ROTH 022 WELDABLE #27

Sm Tube (511-27-10) is a Class IIa device made by Osstem Orthodontics Inc., registered in EUDAMED on 15 Jul 2024 (Basic UDI-DI B-08800033433682), withdrawn as of 25 Oct 2026.

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800033433682 Basic UDI-DI 08800033433682UDI-DIDate15 Jul 2024RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Model / reference
SM TUBE ROTH 022 WELDABLE #27, 511-27-10
Primary DI / UDI-DI
08800033433682
Basic UDI-DI
B-08800033433682
EMDN code
Q010403 Orthodontic brackets and buttons
Device class
Class IIa
EU registration type
Legacy device (under a directive)

Manufacturer details

EUDAMED SRN
KR-MF-000021559
Authorised representative
AR Experts B.V. NL-AR-000023989

Related devices

Category: Orthodontic tube

Similar devices in this category

Other devices filed under ORTHODONTIC BRACKETS AND BUTTONS.

Other devices from Osstem Orthodontics Inc.

See all devices from Osstem Orthodontics Inc. →

Properties

Other properties (12, all answered No)