Skip to content

Medismart

by St.Marys Rubbers Pvt. Ltd. 2 variants

Ref 0LEPP-00S

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 Number8908004933NSEPP1KB Basic UDI-DI 08904448605419UDI-DIDate15 May 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
Non Sterile Latex Examination Powdered
Model / Reference
0LEPP-00S
Primary DI / UDI-DI
08904448605419
Basic UDI-DI
8908004933NSEPP1KB
Direct Marketing DI
08904448605419
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I

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

  • 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