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Immobilizer MTDLI2

by Medtec LLC

Part of a family of 32 devices: see the family page

Ref MTDLI2Model Breast and Pelvis

Immobilizer MTDLI2 is a device classified as Class I in the EU and Class II in the US made by Medtec LLC, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 8419621BREASTPELVISTG), cleared under FDA 510(k) K060737 on 31 Mar 2006 and listed in FDA GUDID since 1 Mar 2018 (UDI-DI 00841439111567), 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 linked in EUDAMED

A group certificate may exist

510(k) K060737

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 Number8419621BREASTPELVISTG Basic UDI-DI 00841439111567UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439111567 UDI-DI Date1 Mar 2018ListedStatusListed GUDID: in commercial distribution
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 8419621BREASTPELVISTG registered 22 May 2026 Active
  • FDA 510(k) K060737 decided 31 Mar 2006 Active
  • FDA GUDID UDI-DI 00841439111567 listed 1 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060737
  2. Listed FDA GUDID 00841439111567
  3. Registered EUDAMED 8419621BREASTPELVISTG

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  • Withdrawn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
Immobilizer
Generic name
Radiological arm/leg positioner
Model / Ref / Catalog
MTDLI2, Breast and Pelvis
Primary DI / UDI-DI
00841439111567
Basic UDI-DI
8419621BREASTPELVISTG
510(k) Number
FDA product code
IYE
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Radiological arm/leg positioner
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
Size
Width — 18.3 Inch
Length — 33.2 Inch

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.

Related devices

Category: Radiological arm/leg positioner

Cleared under the same submission (K060737)

and 8 more cleared under K060737

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)