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SonoScape HD-550Pro

by Sonoscape Medical Corp.

Ref /Model HD-550

SonoScape HD-550Pro is a device classified as Class I in the EU and Class II in the US made by Sonoscape Medical Corp., registered in EUDAMED on 26 Oct 2023 (Basic UDI-DI 69458686HD-550MP), cleared under FDA 510(k) K211882 on 1 Apr 2022 and listed in FDA GUDID since 7 Apr 2022 (UDI-DI 06945868603557), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211882

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69458686HD-550MP Basic UDI-DI 06945868603557UDI-DIDate26 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06945868603557 UDI-DI Date7 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211882 Date1 Apr 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69458686HD-550MP registered 26 Oct 2023 Active
  • FDA 510(k) K211882 decided 1 Apr 2022 Active
  • FDA GUDID UDI-DI 06945868603557 listed 7 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211882
  2. Listed FDA GUDID 06945868603557
  3. Registered EUDAMED 69458686HD-550MP

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  • Withdrawn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
HD-550Pro EUDAMED
SonoScape GUDID
Generic name
Endoscopic video image processing unit
Device name
Image Processor
Model / reference
HD-550 EUDAMED
/ EUDAMED
HD-550Pro GUDID
Primary DI / UDI-DI
06945868603557
Basic UDI-DI
69458686HD-550MP
FDA product code
NWB
EMDN code
Z12020406 Video processors
GMDN term
Endoscopic video image processing unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HD-550
/
GUDID
HD-550Pro
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Endoscopic video image processing unit

Cleared under the same submission (K211882)

and 8 more cleared under K211882

Similar devices in this category

Other devices filed under VIDEO PROCESSORS.

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)