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Terason uSmart3300

by Teratech Corporation

Ref 10-3303Model Terason uSmart3300

Terason uSmart3300 is a hand-held ultrasound imaging system (EU MDR Class IIa; FDA Class II) made by Teratech Corporation, registered in EUDAMED on 23 Oct 2023 (Basic UDI-DI 852698007102HY) and listed in FDA GUDID since 6 Apr 2018 (UDI-DI 00852698007102), 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 Number852698007102HY Basic UDI-DI 00852698007102UDI-DIDate23 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00852698007102 UDI-DI Date6 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 852698007102HY registered 23 Oct 2023 Active
  • FDA GUDID UDI-DI 00852698007102 listed 6 Apr 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00852698007102
  2. Registered EUDAMED 852698007102HY

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  • Withdrawn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
Terason uSmart3300 EUDAMED
Terason GUDID
Generic name
Hand-held ultrasound imaging system, body-surface
Device name
uSmart3300 Ultrasound System
Model / reference
Terason uSmart3300 EUDAMED
10-3303 EUDAMED
uSmart3300 GUDID
Primary DI / UDI-DI
00852698007102
Basic UDI-DI
852698007102HY
Direct marketing DI
00852698007102
FDA product code
IYO, IYN, ITX
EMDN code
Z11040103 Portable ultrasound scanners
GMDN term
Hand-held ultrasound imaging system, body-surface
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560, 892.1550, 892.1570
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Terason uSmart3300
10-3303
GUDID
uSmart3300
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: Hand-held ultrasound imaging system, body-surface

Similar devices in this category

Other devices filed under PORTABLE ULTRASOUND SCANNERS.

Other devices from Teratech Corporation

See all devices from Teratech Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)