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Bite Cup MTHF135

by Medtec LLC

Part of a family of 11 devices: see the family page

Ref MTHF135Model Stereotactic Radiosurgery and Stereotactic Radiotherapy Devices

Bite Cup MTHF135 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 8414391OC0019R01BX), cleared under FDA 510(k) K132908 on 4 Mar 2014 and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 10841439104245), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132908

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8414391OC0019R01BX Basic UDI-DI 10841439104245UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10841439104245 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 8414391OC0019R01BX registered 22 May 2026 Active
  • FDA 510(k) K132908 decided 4 Mar 2014 Active
  • FDA GUDID UDI-DI 10841439104245 listed 2 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132908
  2. Listed FDA GUDID 10841439104245
  3. Registered EUDAMED 8414391OC0019R01BX

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  • Withdrawn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
Bite Cup
Generic name
Stereotactic radiosurgical/radiotherapy arch head frame
Model / Ref / Catalog
MTHF135, Stereotactic Radiosurgery and Stereotactic Radiotherapy Devices
Primary DI / UDI-DI
10841439104245
Basic UDI-DI
8414391OC0019R01BX
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
Netherlands
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)