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Entomed SA203

by Auditdata A/S

Ref SA203Model SA 201, SA202, SA203, SA204

Entomed SA203 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 28 May 2024 (Basic UDI-DI 05711781DHF2009ZW) and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 05711781001241), 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 Number05711781DHF2009ZW Basic UDI-DI 05711781001241UDI-DIDate28 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05711781001241 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 05711781DHF2009ZW registered 28 May 2024 Active
  • FDA GUDID UDI-DI 05711781001241 listed 24 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05711781001241
  2. Registered EUDAMED 05711781DHF2009ZW

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  • Withdrawn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
Entomed SA203 EUDAMED
Entomed By Auditdata GUDID
Generic name
Audiometric/hearing aid tester
Device name
Entomed SA201, SA202, SA203, SA204
Model / reference
SA 201 EUDAMED
SA202 EUDAMED
SA203 EUDAMED
SA204 EUDAMED
SA 203 (English) GUDID
Primary DI / UDI-DI
05711781001241
Basic UDI-DI
05711781DHF2009ZW
Direct marketing DI
05711781001241
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SA 201, SA202, SA203, SA204
SA203
GUDID
SA 203 (English)
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.

Other devices from Auditdata A/S

See all devices from Auditdata A/S →

Properties

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