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Rt-E778KPR2NE

by Qfix

Ref RT-E778KPR2NEModel Aquaplast RT and Fibreplast

Rt-E778KPR2NE is a device classified as Class I in the EU and Class II in the US made by Qfix, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 8419621RTTHERMOPF), cleared under FDA 510(k) K060737 on 31 Mar 2006 (1 earlier submission) and listed in FDA GUDID since 5 Jun 2026 (UDI-DI 00841962120517), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060737

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00841962120517 UDI-DI Date5 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8419621RTTHERMOPF Basic UDI-DI 00841962120517UDI-DIDate22 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK060737 Date31 Mar 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8419621RTTHERMOPF registered 22 May 2026 Active
  • FDA 510(k) K060737 decided 31 Mar 2006 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841962120517 listed 5 Jun 2026 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K935067
  2. Cleared FDA 510(k) K060737
  3. Registered EUDAMED 8419621RTTHERMOPF
  4. Listed FDA GUDID 00841962120517

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Knee / Elbow Extremity Fibreplast
Generic name
Patient positioning thermoplastic mould material
Model / Ref / Catalog
Aquaplast RT and Fibreplast, RT-E778KPR2NE
Primary DI / UDI-DI
00841962120517
Basic UDI-DI
8419621RTTHERMOPF
Unit of use DI
10841962120514
510(k) Number
FDA product code
IYE
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Patient positioning thermoplastic mould material
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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.

Manufacturer details

EUDAMED SRN
US-MF-000002762
Authorised representative
Advena SRL IT-AR-000051131

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Qfix

See all devices from Qfix →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)