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TORS Series 1

by Radley Scientific Limited 8 variants

Ref T1AH

TORS Series 1 (T1AH) is a device classified as Class IIa in the EU and Class II in the US made by Radley Scientific Limited, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 506063477T1AH7J) and listed in FDA GUDID since 24 Jan 2025 (UDI-DI 05060634770323), 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 Number506063477T1AH7J Basic UDI-DI 05060634770323UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060634770323 UDI-DI Date24 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506063477T1AH7J registered 1 Jul 2026 Active
  • FDA GUDID UDI-DI 05060634770323 listed 24 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060634770323
  2. Registered EUDAMED 506063477T1AH7J

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  • Withdrawn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
Single Use, Axial-Grip Handpiece (Single-use – Sterile) EUDAMED
Tors GUDID
Generic name
Hard/soft-tissue ultrasonic surgical system
Device name
TORS Axial-Grip Handpiece (Single-use – Sterile)
Model / Ref / Catalog
T1AH, Series 1
Primary DI / UDI-DI
05060634770323
Basic UDI-DI
506063477T1AH7J
FDA product code
JDX
EMDN code
Z12139085 Various orthopaedic and traumatology instruments - consumables
GMDN term
Hard/soft-tissue ultrasonic surgical system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.4580
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
T1AH
GUDID
Series 1
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Hard/soft-tissue ultrasonic surgical system

Similar devices in this category

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

Other devices from Radley Scientific Limited

See all devices from Radley Scientific Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)