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Dental Sleeves

by Huanghua Promisee Dental Co.Ltd. 51 variants

Ref /Model DS01A,DS01B,DS02A,DS02B,DS03A,DS04A,DS05A,DS09B

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69544540DESL001NX Basic UDI-DI 06954454011805UDI-DIDate19 Mar 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
DS01A, DS01B, DS02A, DS02B, DS03A, DS04A, DS05A, DS09B, /
Primary DI / UDI-DI
06954454011805
Basic UDI-DI
69544540DESL001NX
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000014766
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Reprocessed

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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