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Primus Ice

by Auditdata A/S

Ref 90.3030Model 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+

Primus Ice (90.3030) 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 24 Aug 2016 (UDI-DI 05711781001098), 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
European UnionCE/MDR EUDAMED Number05711781DHF2000ZC Basic UDI-DI 05711781001098UDI-DIDate21 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05711781001098 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 05711781DHF2000ZC registered 21 Mar 2024 Active
  • FDA GUDID UDI-DI 05711781001098 listed 24 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05711781001098
  2. Registered EUDAMED 05711781DHF2000ZC

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  • Withdrawn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

Trade name
Primus Ice EUDAMED
Primus By Auditdata GUDID
Generic name
Audiometric/hearing aid tester
Device name
2000 Fitting Unit, Primus Ice, 2000-1 FU
Model / reference
2000-1 Fitting Unit - Unity 4 EUDAMED
Measure EUDAMED
2000 Primus Pro EUDAMED
Ice EUDAMED
PFU+ EUDAMED
90.3030 EUDAMED
2000 Primus Fitting Unit Ice GUDID
Primary DI / UDI-DI
05711781001098
Basic UDI-DI
05711781DHF2000ZC
Direct marketing DI
05711781001098
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
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+
90.3030
GUDID
2000 Primus Fitting Unit Ice
Device classEUDAMED
Class IIa
GUDID
Class II

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

Similar devices in this category

Other devices filed under AUDIOMETERS.

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Properties

  • Measuring function
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)