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Natural Powder Free Premium Latex Examination Gloves

by Oon Corp Resources (M) Sdn Bhd 5 variants

Ref www.ooncorp.comModel PCT2300, PCT2200

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 Number955591900PCT2300-15G Basic UDI-DI Date11 Mar 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Latex Examination Gloves, Powder Free Non-sterile
Model / Reference
PCT2300, www.ooncorp.com, PCT2200
Primary DI / UDI-DI
09555919000111, 09555919001637
Basic UDI-DI
955591900PCT2300-15G, 955591900PCT2200-155
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000015791
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Oon Corp Resources (M) Sdn Bhd

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Properties

  • Contains Latex
  • Administering Medicine NoEUDAMEDYesEUDAMED

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No