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trUpoint ARCH™ MTHF01

by Medtec LLC

Part of a family of 26 devices: see the family page

Ref MTHF01Model Head and Neck

trUpoint ARCH MTHF01 is a medical device (EU MDR Class I; FDA Class II; FDA product code IYE, Accelerator, linear, medical; EMDN category patient positioning instruments - hardware accessories) made by Medtec LLC, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 8419621HEADNECKX4), cleared under FDA 510(k) K132908 on 4 Mar 2014 and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 00841439104217), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132908

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8419621HEADNECKX4 Basic UDI-DI 00841439104217UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439104217 UDI-DI Date2 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132908 Date4 Mar 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8419621HEADNECKX4 registered 22 May 2026 Active
  • FDA 510(k) K132908 decided 4 Mar 2014 Active
  • FDA GUDID UDI-DI 00841439104217 listed 2 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132908
  2. Listed FDA GUDID 00841439104217
  3. Registered EUDAMED 8419621HEADNECKX4

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  • Withdrawn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
trUpoint ARCH™
Generic name
Stereotactic radiosurgical/radiotherapy arch head frame
Model / Ref / Catalog
MTHF01, Head and Neck
Primary DI / UDI-DI
00841439104217
Basic UDI-DI
8419621HEADNECKX4
510(k) Number
FDA product code
IYE
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Stereotactic radiosurgical/radiotherapy arch head frame
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Italy
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.

Related devices

Category: Stereotactic radiosurgical/radiotherapy arch head frame

Cleared under the same submission (K132908)

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)