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Nulatex Probe cover, Ø 34mm (non-lubricated)

by Nulatex Sdn. Bhd.

Ref NSB-P-0001Model Nulatex Probe cover, Ø 34mm (non-lubricated)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955531350NSBPCHR Basic UDI-DI 09555313502129UDI-DIDate12 Sep 2024RegisteredStatusActive

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  • Withdrawn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
Probe cover, Ø 34mm (non-lubricated)
Model / Reference
Nulatex Probe cover, Ø 34mm (non-lubricated), NSB-P-0001
Primary DI / UDI-DI
09555313502129
Basic UDI-DI
955531350NSBPCHR
EMDN Code
Z11040299 Ultrasound probes – other
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
MY-MF-000018099
Authorised representative
Advena Limited MT-AR-000000234

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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