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Medical ultrasound gel

by Dongguan Hongyuan Pharmaceutical Technology

Ref 5g/tubeModel 5g/tube,10g/tube,12g/tube,15g/tube, 20g/tube,25g/tube,30g/tube,50g/tube,60g/tube, 100g/tube,250g/tube,500g/tube

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69248575ultrasoundgel4G Basic UDI-DI 06924857500008UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Medical ultrasound gel
Model / Reference
5g/tube, 10g/tube, 12g/tube, 15g/tube, 20g/tube, 25g/tube, 30g/tube, 50g/tube, 60g/tube, 100g/tube, 250g/tube, 500g/tube
Primary DI / UDI-DI
06924857500008
Basic UDI-DI
69248575ultrasoundgel4G
EMDN Code
Z12010885 Instruments for ultrasonic surgery - consumables
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000054519
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Dongguan Hongyuan Pharmaceutical Technology

Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No