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Seraflex

by PT. Medisafe Technologies 8 variants

Ref NIT-SG-81-OWModel Seraflex

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number899703030NTSGS7 Basic UDI-DI 08997030302568UDI-DIDate23 Apr 2026RegisteredStatusActive

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  • Withdrawn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 Nitrile Sterile Surgical Gloves
Model / Reference
Seraflex, NIT-SG-81-OW
Primary DI / UDI-DI
08997030302568
Basic UDI-DI
899703030NTSGS7
EMDN Code
T01010202 Nitrile 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

Other properties (12)

  • 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