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Prophy Strip

by Huanghua Promisee Dental Co.Ltd. 3 variants

Ref PS13B, /, PS13A, PS13CModel PS01 Type I, PS01 Type II

Prophy Strip (PS13B) is a Class I device made by Huanghua Promisee Dental Co.Ltd., registered in EUDAMED on 20 Mar 2025 (Basic UDI-DI 69544540PRST0014F), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69544540PRST0014F Basic UDI-DI Date20 Mar 2025RegisteredStatusActive

Official records

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  • Withdrawn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
PS01 Type I, PS01 Type II, PS13B, /, PS13A, PS13C
Primary DI / UDI-DI
06954454013953, 06954454004715, 06954454013946, 06954454013960, 06954454004722
Basic UDI-DI
69544540PRST0014F
EMDN code
Q010599 Dental instruments, single-use - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Cyprus
France
Austria
Bulgaria
Italy

Manufacturer details

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

Other devices from Huanghua Promisee Dental Co.Ltd.

See all devices from Huanghua Promisee Dental Co.Ltd. →

Properties

  • Reprocessed single-use device
Other properties (13, all answered No)