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Compact Touch 2017

by Quantel Medical

Ref COMPACT TOUCH

Compact Touch 2017 is an ophthalmic ultrasound imaging system (EU MDR Class IIa; FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Quantel Medical, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 37005426COMPACTTOUCHJX), cleared under FDA 510(k) K180265 on 2 Mar 2018 and listed in FDA GUDID since 13 Apr 2018 (UDI-DI 03700542625545), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180265

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number37005426COMPACTTOUCHJX Basic UDI-DI 03700542625545UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700542625545 UDI-DI Date13 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180265 Date2 Mar 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 37005426COMPACTTOUCHJX registered 28 May 2026 Active
  • FDA 510(k) K180265 decided 2 Mar 2018 Active
  • FDA GUDID UDI-DI 03700542625545 listed 13 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180265
  2. Listed FDA GUDID 03700542625545
  3. Registered EUDAMED 37005426COMPACTTOUCHJX

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  • Withdrawn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
Compact Touch
Generic name
Ophthalmic ultrasound imaging system
Model / reference
COMPACT TOUCH EUDAMED
COMPACT TOUCH 2017 GUDID
Primary DI / UDI-DI
03700542625545
Basic UDI-DI
37005426COMPACTTOUCHJX
510(k) Number
FDA product code
IYO
EMDN code
Z11040107 Echophthalmographs
GMDN term
Ophthalmic ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
COMPACT TOUCH
GUDID
COMPACT TOUCH 2017
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 system

Cleared under the same submission (K180265)

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)