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A Standardized Probe Std-A

by Quantel Medical

Part of a family of 7 devices: see the family page

Ref STD-A

A Standardized Probe Std-A is an ophthalmic ultrasound imaging transducer (EU MDR Class IIa; FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Quantel Medical, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 37005426ABSOLUAP), cleared under FDA 510(k) K051851 on 3 Aug 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 03700542625118), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K051851

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number37005426ABSOLUAP Basic UDI-DI 03700542625118UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700542625118 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK051851 Date3 Aug 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 37005426ABSOLUAP registered 28 May 2026 Active
  • FDA 510(k) K051851 decided 3 Aug 2005 Active
  • FDA GUDID UDI-DI 03700542625118 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K051851
  2. Listed FDA GUDID 03700542625118
  3. Registered EUDAMED 37005426ABSOLUAP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
STD-A Probe 8MHz (STD-A) EUDAMED
A Standardized Probe GUDID
Generic name
Ophthalmic ultrasound imaging transducer
Device name
Absolu
Model / reference
Std-A
Primary DI / UDI-DI
03700542625118
Basic UDI-DI
37005426ABSOLUAP
510(k) Number
FDA product code
ITX
EMDN code
Z11040107 Echophthalmographs
GMDN term
Ophthalmic ultrasound imaging transducer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Ophthalmic ultrasound imaging transducer

Cleared under the same submission (K051851)

Similar devices in this category

Other devices filed under ECHOPHTHALMOGRAPHS.

Other devices from Quantel Medical

See all devices from Quantel Medical →

Properties

  • Measuring function
  • Serial number
Other properties (23, all answered No)