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Terason 5C2A

by Teratech Corporation

Ref 10-3278Model Terason 5C2A

Terason 5C2A (10-3278) is a hand-held ultrasound imaging system (EU MDR Class IIa; FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Teratech Corporation, registered in EUDAMED on 23 Oct 2023 (Basic UDI-DI 852698007010HS) with CE/MDR certificate 28620253687 valid until 1 Mar 2031 and listed in FDA GUDID since 6 Apr 2018 (UDI-DI 00852698007010), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

1 Mar 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number28620253687 Date13 Aug 2026IssuedStatusActive expires 1 Mar 2031
United StatesGUDID listing GUDID Number00852698007010 UDI-DI Date6 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 852698007010HS registered 23 Oct 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00852698007010 listed 6 Apr 2018 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

4 dated events

  1. Listed FDA GUDID 00852698007010
  2. Registered EUDAMED 852698007010HS
  3. Certificate issued EUDAMED 28620253687
  4. Certificate expires EUDAMED 28620253687

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  • Withdrawn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 5C2A EUDAMED
Terason GUDID
Generic name
Hand-held ultrasound imaging system, body-surface
Device name
5C2A Transducer
Model / reference
Terason 5C2A EUDAMED
10-3278 EUDAMED
15L4 GUDID
Primary DI / UDI-DI
00852698007010
Basic UDI-DI
852698007010HS
Direct marketing DI
00852698007010
FDA product code
ITX
EMDN code
Z11040299 Ultrasound probes – other
GMDN term
Hand-held ultrasound imaging system, body-surface
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
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 5C2A
10-3278
GUDID
15L4
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
US-MF-000033295
Authorised representative
Wellkang Ltd XI-AR-000001836

Similar devices in this category

Other devices filed under ULTRASOUND PROBES – OTHER.

Other devices from Teratech Corporation

See all devices from Teratech Corporation →

Properties

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