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Blue Powder Free Premium Latex Examination Gloves

by Oon Corp Resources (M) Sdn Bhd 2 variants

Ref www.ooncorp.comModel SCH1260

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 Number955591900SCH1260-1ZQ Basic UDI-DI Date22 Apr 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  • Withdrawn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, Blue Powder Free Non-Sterile
Model / Reference
SCH1260, www.ooncorp.com
Primary DI / UDI-DI
09555919000173, 09555919000197, 09555919000180
Basic UDI-DI
955591900SCH1260-1ZQ
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

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

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Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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