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Portable X-ray equipment

by REMEDI Inc.

Ref REM-IFU-T(K)100_Instruction For Use, REM-IFU-KA6Model REMEX-T100, REMEX-KA6

Portable X-ray equipment (REMEX-T100) is a portable basic diagnostic x-ray system (EU MDD Class IIb; FDA Class II; FDA product code IZI, System, X-Ray, Angiographic) made by REMEDI Inc., registered in EUDAMED on 1 Apr 2025 (Basic UDI-DI B-08800060100014), cleared under FDA 510(k) K212144 on 3 Aug 2021 and listed in FDA GUDID since 13 Apr 2022 (UDI-DI 08800060100014), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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) K212144

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/MDD EUDAMED NumberB-08800060100014 Basic UDI-DI Date1 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08800060100014 UDI-DI Date13 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212144 Date3 Aug 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800060100014 registered 1 Apr 2025 Active
  • FDA 510(k) K212144 decided 3 Aug 2021 Active
  • FDA GUDID UDI-DI 08800060100014 listed 13 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212144
  2. Listed FDA GUDID 08800060100014
  3. Registered EUDAMED B-08800060100014

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Remex-KA6 EUDAMED
Remex KA6 GUDID
Generic name
Portable basic diagnostic x-ray system, digital
Device name
Portable X-ray equipment
Model / reference
REMEX-T100 EUDAMED
REM-IFU-T(K)100_Instruction For Use EUDAMED
REMEX-KA6 EUDAMED
REM-IFU-KA6 EUDAMED
REMEX KA6 GUDID
Primary DI / UDI-DI
08800060100014, 08800060100151
Basic UDI-DI
B-08800060100014, 88000601REMEX-WBS6, B-08800060100151
Direct marketing DI
08800060100151
510(k) Number
FDA product code
IZI
EMDN code
Z11039016 Mobile radiographic units
GMDN term
Portable basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1600
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Portugal
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REMEX-T100
REM-IFU-T(K)100_Instruction For Use
REMEX-KA6
REM-IFU-KA6
GUDID
REMEX KA6
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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
KR-MF-000026327
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Similar devices in this category

Other devices filed under MOBILE RADIOGRAPHIC UNITS.

Other devices from REMEDI Inc.

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)