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Gima

by Razormed Inc. 18 variants

Ref 27064

Expiring European Union

CE MDR

Valid until

14 Jul 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

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 Number28620239980 Date6 Mar 2026IssuedStatusExpiring expires 14 Jul 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Disposable Scalpels including safety types
Model / Reference
27064
Primary DI / UDI-DI
18903376032455
Basic UDI-DI
8903376DSWG
Unit of Use DI
08903376032458
EMDN Code
V010101 Scalpels with safety systems, single-use
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000012812
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Razormed Inc.

  • Derma Steel Fine

    Class IIa

  • Gima

    Class IIa

  • Kent Dental

    Class IIa

  • Razormed

    Class IIa

  • Diamantine

    Class IIa

  • Diamantine

    Class IIa

See all devices from Razormed Inc. →

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