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Dml 3000

by QIAGEN Sciences LLC

Ref 5000-00031

Dml 3000 (5000-00031) is a device classified as Class A in the EU and Class III in the US made by QIAGEN Sciences LLC, registered in EUDAMED on 5 May 2026 (Basic UDI-DI 4053228IHC2DML0000000017V), approved under FDA PMA P890064 on 11 Mar 1991 and listed in FDA GUDID since 21 Dec 2016 (UDI-DI 04053228010777), active as of 22 Oct 2026.

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

CE IVDR PMA

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

PMA P890064

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/IVDR EUDAMED Number4053228IHC2DML0000000017V Basic UDI-DI 04053228010777UDI-DIDate5 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053228010777 UDI-DI Date21 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP890064 Date11 Mar 1991DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4053228IHC2DML0000000017V registered 5 May 2026 Active
  • FDA PMA P890064 decided 11 Mar 1991 Active
  • FDA GUDID UDI-DI 04053228010777 listed 21 Dec 2016 Listed

Timeline

3 dated events

  1. Approved FDA PMA P890064
  2. Listed FDA GUDID 04053228010777
  3. Registered EUDAMED 4053228IHC2DML0000000017V

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Generic name
Photometer, absorbance/transmission, automated
Device name
digene Microplate Luminometer 3000 (DML 3000)
Model / Ref / Catalog
5000-00031, 1
Primary DI / UDI-DI
04053228010777
Basic UDI-DI
4053228IHC2DML0000000017V
Direct marketing DI
04053228010777
PMA number
FDA product code
MAQ
EMDN code
W02050199 Nucleic acid testing instruments except micro-arrays - other
GMDN term
Photometer, absorbance/transmission, automated
Device class
Class A EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
5000-00031
GUDID
1
Device classEUDAMED
Class A
GUDID
Class III

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

Manufacturer details

EUDAMED SRN
US-MF-000014502
Authorised representative
QIAGEN GmbH DE-AR-000004971

Similar devices in this category

Other devices filed under NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER.

Other devices from QIAGEN Sciences LLC

See all devices from QIAGEN Sciences LLC →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (22, all answered No)