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Smpl

by Smit Medimed Private Limited 5 variants

Ref MAS001

Active European Union

CE MDD

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/MDD NumberB-08909027000036 Basic UDI-DI 08909027000036UDI-DIDate4 Jul 2024RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Monoaxial screw
Model / Reference
MAS001
Primary DI / UDI-DI
08909027000036
Basic UDI-DI
B-08909027000036
EMDN Code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
IN-MF-000023289
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Smit Medimed Private Limited

  • Smpl

    Class IIb

  • Smpl

    Class IIb

  • Smpl

    Class IIb

  • Smpl

    Class IIb

Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No