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TORS Series 1

by Radley Scientific Limited 8 variants

Ref P4S2

TORS Series 1 (P4S2) 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 30 Jun 2026 (Basic UDI-DI 506063477P4S27H) and listed in FDA GUDID since 1 Oct 2024 (UDI-DI 05060634771115), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506063477P4S27H Basic UDI-DI 05060634771115UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060634771115 UDI-DI Date1 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506063477P4S27H registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI 05060634771115 listed 1 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060634771115
  2. Registered EUDAMED 506063477P4S27H

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  • Withdrawn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 200mm Ø4mm Piercer Probe (Single-use - Sterile) EUDAMED
Tors GUDID
Generic name
Hard/soft-tissue ultrasonic surgical system
Device name
TORS Piercer Probe (Single-use – Sterile)
Model / Ref / Catalog
P4S2, Series 1
Primary DI / UDI-DI
05060634771115
Basic UDI-DI
506063477P4S27H
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 — 200 Millimeter
Outer Diameter — 4 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
P4S2
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)