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Mycophenolic Acid Control

by More Diagnostics Inc

Ref 240

Mycophenolic Acid Control (240) is a device classified as Class C in the EU and Class I in the US made by More Diagnostics Inc, registered in EUDAMED on 11 Feb 2026 (Basic UDI-DI 0856743007MDI02406D), cleared under FDA 510(k) K072257 on 30 Jan 2008 and listed in FDA GUDID since 5 Apr 2018 (UDI-DI 00856743007062), active as of 24 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K072257

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0856743007MDI02406D Basic UDI-DI 00856743007062UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00856743007062 UDI-DI Date5 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK072257 Date30 Jan 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0856743007MDI02406D registered 11 Feb 2026 Active
  • FDA 510(k) K072257 decided 30 Jan 2008 Active
  • FDA GUDID UDI-DI 00856743007062 listed 5 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K072257
  2. Listed FDA GUDID 00856743007062
  3. Registered EUDAMED 0856743007MDI02406D

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MPA Control
Generic name
Mycophenolate therapeutic drug monitoring IVD, control
Model / Ref / Catalog
240
Primary DI / UDI-DI
00856743007062
Basic UDI-DI
0856743007MDI02406D
Direct marketing DI
00856743007062
510(k) Number
FDA product code
LAS
EMDN code
W0102152001 Tdm/drug controls
GMDN term
Mycophenolate therapeutic drug monitoring IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.3280
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class I

Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000019469
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Similar devices in this category

Other devices filed under TDM/DRUG CONTROLS.

Other devices from More Diagnostics Inc

See all devices from More Diagnostics Inc →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)