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107101MR

by Medtec LLC

Part of a family of 108 devices: see the family page

Ref 107101MRModel Head, Neck, and Shoulder Devices

107101MR 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 8414391OC0005R01AQ), cleared under FDA 510(k) K180021 on 29 Jun 2018 and listed in FDA GUDID since 22 Oct 2025 (UDI-DI 00841439114605), 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) K180021

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 Number8414391OC0005R01AQ Basic UDI-DI 00841439114605UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439114605 UDI-DI Date22 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180021 Date29 Jun 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8414391OC0005R01AQ registered 22 May 2026 Active
  • FDA 510(k) K180021 decided 29 Jun 2018 Active
  • FDA GUDID UDI-DI 00841439114605 listed 22 Oct 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180021
  2. Listed FDA GUDID 00841439114605
  3. Registered EUDAMED 8414391OC0005R01AQ

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  • Withdrawn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
Wedge
Generic name
Radiological headrest
Model / Ref / Catalog
Head, Neck, and Shoulder Devices, 107101MR
Primary DI / UDI-DI
00841439114605
Basic UDI-DI
8414391OC0005R01AQ
510(k) Number
FDA product code
LNH, IYE
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Radiological headrest
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1000, 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.

Manufacturer details

EUDAMED SRN
US-MF-000002608
Authorised representative
CEpartner4U NL-AR-000000111

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

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)