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Ultrasonic Scaler Handpiece

by Guilin Refine Medical Instrument Co., Ltd. 5 variants

Ref HP-5LModel HP-3H, HP-5L, HS-7H, HS-7L, HY-2L

Active European Union

CE MDR CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06971560453282 Basic UDI-DI 06971560453282UDI-DIDate12 Dec 2024RegisteredStatusActive
European UnionCE/MDD NumberB-06971560453282 Basic UDI-DI 06971560453282UDI-DIDate12 Dec 2024RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Model / Reference
HP-5L, HP-3H, HS-7H, HS-7L, HY-2L
Primary DI / UDI-DI
06971560453282
Basic UDI-DI
B-06971560453282, 697156045USHTX
Direct Marketing DI
06971560453282
EMDN Code
Z12119006 Dental cleaning/washing handpiece equipments
Device Class
Class IIa
EU market of registration
Germany
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000012204
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Other devices from Guilin Refine Medical Instrument Co., Ltd.

See all devices from Guilin Refine Medical Instrument Co., Ltd. →

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