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Smpl

by Smit Medimed Private Limited 5 variants

Ref PAS001, ACP001, S029-05, S151-6.5-220, S391.S09.18

Active European Union

CE MDR 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08909027000043 Basic UDI-DI Date4 Jul 2024RegisteredStatusActive
European UnionCE/MDD NumberB-08909027000043 Basic UDI-DI Date4 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  • Withdrawn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/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Polyaxial screw
Anterior Cervical Plates
Limited Contact Self Compression Plate Narrow, Dia. 4.5 Mm Narrow, 5 Hole, Ss
HUMERAS INTERLOCKING NAIL Dia. 6.5mm x Size 220mm, SS
Antirotation Proximal Femoral Nail Short Dia. 9.0 x Length 180mm
Model / Reference
PAS001, ACP001, S029-05, S151-6.5-220, S391.S09.18
Primary DI / UDI-DI
08909027000043, 08909027000029, 08909027003440, 08909027002863, 08909027000005
Basic UDI-DI
B-08909027000043, B-08909027000029, 8909027S029-05DT, 8909027S151-6.5-220MV, 8909027S391.S09.18XU
Direct Marketing DI
08909027003440
08909027002863
08909027000005
EMDN Code
P09120699, P09120503, P09120501, P09120599, P09120201
Device Class
Class IIb
EU market of registration
Spain
Germany

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

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  • Smpl

    Class IIb

  • Smpl

    Class IIb

Properties

  • Implantable
  • Sutures
  • Human Tissues NoEUDAMEDYesEUDAMED
  • Administering Medicine NoEUDAMEDYesEUDAMED

Other properties (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No