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TORS Series 1

by Radley Scientific Limited 8 variants

Ref P6S1

TORS Series 1 (P6S1) is a device classified as Class IIb in the EU and Class II in the US made by Radley Scientific Limited, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 506063477PSXSXGN) and listed in FDA GUDID since 13 Nov 2024 (UDI-DI 05060634771146), 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 Number506063477PSXSXGN Basic UDI-DI 05060634771146UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060634771146 UDI-DI Date13 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506063477PSXSXGN registered 1 Jul 2026 Active
  • FDA GUDID UDI-DI 05060634771146 listed 13 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060634771146
  2. Registered EUDAMED 506063477PSXSXGN

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  • Withdrawn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
Cement 100mm Ø6mm Piercer Probe (Single-use - Sterile) EUDAMED
Tors GUDID
Generic name
Hard/soft-tissue ultrasonic surgical system
Device name
TORS Cement Probes (Single-use – Sterile)
Model / Ref / Catalog
P6S1, Series 1
Primary DI / UDI-DI
05060634771146
Basic UDI-DI
506063477PSXSXGN
FDA product code
JDX
EMDN code
Z12139002 Prosthetic cement removal equipment
GMDN term
Hard/soft-tissue ultrasonic surgical system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.4580
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 100 Millimeter
Outer Diameter — 6 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
P6S1
GUDID
Series 1
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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.

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)