Skip to content

Durasense

by PT. Medisafe Technologies 3 variants

Ref Powder Free Natural Rubber Latex Sterile SurgicalGlovesModel Durasense

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 linked in EUDAMED

A group certificate may exist

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 Number899703030NRSGRV Basic UDI-DI 08997030303046UDI-DIDate24 Feb 2023RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Powder Free Natural Rubber Latex Sterile Surgical Gloves
Model / Reference
Durasense, Powder Free Natural Rubber Latex Sterile SurgicalGloves
Primary DI / UDI-DI
08997030303046
Basic UDI-DI
899703030NRSGRV
EMDN Code
T01010102 Non-powdered latex surgical gloves
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
ID-MF-000017133
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from PT. Medisafe Technologies

See all devices from PT. Medisafe Technologies →

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