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Smartex

by St.Marys Rubbers Pvt. Ltd. EUDAMED

Active European Union

Ref 1LEPP-11S

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8908004933SLEPP1JX Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

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.

Specification

EUDAMED

Device Name
Sterile Latex Examination Gloves – Powdered (ETO)
Model / Reference
1LEPP-11S
Primary DI / UDI-DI
08904448605112
Basic UDI-DI
8908004933SLEPP1JX
Direct Marketing DI
08904448605112
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
IN-MF-000008817
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from St.Marys Rubbers Pvt. Ltd.

See all devices from St.Marys Rubbers Pvt. Ltd. →

Properties

  • Sterile
  • Contains Latex

Other properties (11)

  • 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