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Unity 4, Measure

by Auditdata A/S

Ref 100.310Model 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+

Unity 4, Measure (100.310) is a device classified as Class IIa in the EU and Class II in the US made by Auditdata A/S, registered in EUDAMED on 21 Mar 2024 (Basic UDI-DI 05711781DHF2000ZC) and listed in FDA GUDID since 21 Aug 2024 (UDI-DI 05711781002705), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05711781002705 UDI-DI Date21 Aug 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number05711781DHF2000ZC Basic UDI-DI 05711781002705UDI-DIDate21 Mar 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 05711781DHF2000ZC registered 21 Mar 2024 Active
  • FDA GUDID UDI-DI 05711781002705 listed 21 Aug 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 05711781DHF2000ZC
  2. Listed FDA GUDID 05711781002705

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Audiometric/hearing aid tester
Device name
2000 Fitting Unit, Primus Ice, 2000-1 FU
Model / Ref / Catalog
2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+, 100.310, Fitting Unit Package (2000-1)
Primary DI / UDI-DI
05711781002705 EUDAMED
05711781003078 GUDID
Basic UDI-DI
05711781DHF2000ZC
FDA product code
EWO
EMDN code
Z121401 Audiometers
GMDN term
Audiometric/hearing aid tester
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+
100.310
GUDID
Fitting Unit Package (2000-1)
Primary DI / UDI-DIEUDAMED
05711781002705
GUDID
05711781003078
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 05711781002705; FDA GUDID lists 05711781003078), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa 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
DK-MF-000011415

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Properties

  • Measuring function
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)