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Diagnostic Ultrasound System

by Shenzhen Comen Medical Instruments Co., LTD. 10 variants

Ref EP50 Exp, EP30ST, EP AirSon, EP Taur, EP50 Pro, EP30 Exp, EP30PT, EP30PR, EP50PR, EP50PA, EP30 Pro, EP50 Neo, EP Sagi, EP50ST, EP PreSon, EP30SE, EP30 Neo, EP50 Plus, EP30Model EP50

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69454290DU001LW Basic UDI-DI Date25 Mar 2026RegisteredStatusActive EUDAMED: not on the EU market

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
EP50, EP50 Exp, EP30ST, EP AirSon, EP Taur, EP50 Pro, EP30 Exp, EP30PT, EP30PR, EP50PR, EP50PA, EP30 Pro, EP50 Neo, EP Sagi, EP50ST, EP PreSon, EP30SE, EP30 Neo, EP50 Plus, EP30
Primary DI / UDI-DI
06945429028065, 06945429028287, 06945429028317, 06945429028294, 06945429028058, 06945429028195, 06945429028232, 06945429002829, 06945429028102, 06945429028126, 06945429028188, 06945429028089, 06945429028300, 06945429028164, 06945429028324, 06945429028263, 06945429028218, 06945429028072, 06945429028171
Basic UDI-DI
69454290DU001LW
Direct Marketing DI
06945429028065
06945429028287
06945429028317
06945429028294
06945429028058
06945429028195
06945429028232
06945429002829
06945429028102
06945429028126
06945429028188
06945429028089
06945429028300
06945429028164
06945429028324
06945429028263
06945429028218
06945429028072
06945429028171
EMDN Code
Z11040103 Portable ultrasound scanners
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000002236
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Comen Medical Instruments Co., LTD.

See all devices from Shenzhen Comen Medical Instruments Co., LTD. →

Properties

  • Measuring Function

Other properties (12)

  • Sterile: 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
  • Incorporates Medicinal Product: No