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Nitrile Gloves

by Tan Sin Lian Industries Sdn. Bhd. 2 variants

Ref NTPF

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 Number955569750NTPFV8 Basic UDI-DI Date16 Mar 2023RegisteredStatusActive

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  • Withdrawn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
NTPF
Primary DI / UDI-DI
09555697505174, 09555697505204, 09555697505181, 09555697505198
Basic UDI-DI
955569750NTPFV8
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
MY-MF-000024147
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Tan Sin Lian Industries Sdn. Bhd.

See all devices from Tan Sin Lian Industries Sdn. Bhd. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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