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PLP Ultrasonic Probe Cover (Non-Sterile)

by Pleasure Latex Products Sdn. Bhd. 2 variants

Ref PLPPC-L-14451, 0041, 0043

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K022156↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-19555012422213 Basic UDI-DI Date30 Jun 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK022156 Date11 Sep 2003IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Trade Name
PLP Ultrasonic Probe Cover (Non-Sterile)
Plp Ultrasonic Probe Cover
Device Name
Non-Sterile Natural Rubber Latex Ultrasonic Probe Covers
Non-Sterile Natural Rubber Latex Ultrasonic Prove Covers
Natural Rubber Latex Probe Cover
Model / Reference
PLPPC-L-14451, 0041, 0043
Primary DI / UDI-DI
19555012422213, 19555012421599, 19555012421513, 19555012421506, 19555012421285, 19555012421551
Basic UDI-DI
B-19555012422213, B-19555012421599, B-19555012421513, B-19555012421506, B-19555012421285, B-19555012421551
EMDN Code
T030199 Covers, instruments and equipment - other
Device Class
Class IIa
EU market of registration
Czechia
France
Greece

Manufacturer details

EUDAMED SRN
MY-MF-000016199
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Pleasure Latex Products Sdn. Bhd.

See all devices from Pleasure Latex Products Sdn. Bhd. →

Properties

  • Contains Latex

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No