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12LT-A

by Sonoscape Medical Corp. 3 variants

Model 12L-A

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69458686P1001QJ Basic UDI-DI 06945868603144UDI-DIDate29 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06945868603144 UDI-DI Date1 Apr 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
12LT-A EUDAMED
SonoScape GUDID
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held
Device Name
Ultrasonic Transducer
Model / Reference
12L-A EUDAMED
12LT-A GUDID
Primary DI / UDI-DI
06945868603144
Basic UDI-DI
69458686P1001QJ
Direct Marketing DI
06945868603144
510(k) Number
FDA Product Code
ITX, IYO, IYN
EMDN Code
Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1560, 892.1550
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
12L-A
GUDID
12LT-A
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000009623
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No