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Orthex Tool RB-155B

by Orthopediatrics Corp.

Part of a family of 21 devices: see the family page

Ref RB-155BModel 01-1007-0001

Orthex Tool RB-155B is a device classified as Class I in the EU and Class II in the US made by Orthopediatrics Corp., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 0841132109PLSTUN) and listed in FDA GUDID since 28 Feb 2020 (UDI-DI 00841132180532), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841132109PLSTUN Basic UDI-DI 00841132180532UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132180532 UDI-DI Date28 Feb 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0841132109PLSTUN registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00841132180532 listed 28 Feb 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841132180532
  2. Registered EUDAMED 0841132109PLSTUN

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  • Withdrawn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
Orthopediatrics® Orthex External Fixation System Instructions for Use EUDAMED
Orthex Tool GUDID
Generic name
External orthopaedic fixation system noninvasive component, single-use
Device name
Orthopediatrics® Instrumentation
Model / Ref / Catalog
RB-155B, 01-1007-0001
Primary DI / UDI-DI
00841132180532
Basic UDI-DI
0841132109PLSTUN
FDA product code
KTT
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
External orthopaedic fixation system noninvasive component, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: External orthopaedic fixation system noninvasive component, single-use

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)