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Dental High Speed handpiece

by DTL Dental Equipment Manufacture Co., Ltd. 20 variants

Ref HP45Model HP0,HP0B2,HP3,HP3KL,HP4,HP4KL,HP1,HP1K,HP1KL,HP1NL,HP2,HP2K,HP2KL,HP2NL,HP45,HP45K,HP45KL

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697752922HPHS01TL Basic UDI-DI 06977529220148UDI-DIDate21 Jul 2026RegisteredStatusActive

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  • Withdrawn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
HP0, HP0B2, HP3, HP3KL, HP4, HP4KL, HP1, HP1K, HP1KL, HP1NL, HP2, HP2K, HP2KL, HP2NL, HP45, HP45K, HP45KL
Primary DI / UDI-DI
06977529220148
Basic UDI-DI
697752922HPHS01TL
Direct Marketing DI
06977529220148
EMDN Code
Z12110101 Dental treatment units
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000047839
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from DTL Dental Equipment Manufacture Co., Ltd.

See all devices from DTL Dental Equipment Manufacture 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