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LT-Thermoplastic™

by CDR Systems Inc.

Part of a family of 44 devices: see the family page

Ref Multiple catalogue numbers in ThermoplasticModel LT-Thermoplastic™ and Solid Bolus Series

LT-Thermoplastic™ is a device classified as Class I in the EU and Class II in the US made by CDR Systems Inc, registered in EUDAMED on 6 May 2026 (Basic UDI-DI 62834193048H), cleared under FDA 510(k) K122888 on 30 Apr 2013 and listed in FDA GUDID since 31 Dec 2019 (UDI-DI 00628341930222), active as of 22 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 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K122888

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number62834193048H Basic UDI-DI 00628341930222UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00628341930222 UDI-DI Date31 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122888 Date30 Apr 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 62834193048H registered 6 May 2026 Active
  • FDA 510(k) K122888 decided 30 Apr 2013 Active
  • FDA GUDID UDI-DI 00628341930222 listed 31 Dec 2019 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K122888
  2. Listed FDA GUDID 00628341930222
  3. Registered EUDAMED 62834193048H

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  • Withdrawn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
LT-Thermoplastic™ EUDAMED
Thermoplastic GUDID
Generic name
Patient positioning thermoplastic mould material
Model / reference
LT-Thermoplastic™ and Solid Bolus Series EUDAMED
Multiple catalogue numbers in Thermoplastic EUDAMED
1 GUDID
Primary DI / UDI-DI
00628341930222
Basic UDI-DI
62834193048H
510(k) Number
FDA product code
IYE
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
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
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
LT-Thermoplastic™ and Solid Bolus Series
Multiple catalogue numbers in Thermoplastic
GUDID
1
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
CA-MF-000051790
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from CDR Systems Inc

See all devices from CDR Systems Inc →

Properties

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