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Imp. Strong Sw Plus He Ø4.5x11.5mm

by S.I.N. Implant System Ltda.

Ref SWHE 4511NModel DENTAL IMPLANTS WITH HYDROXYAPATITE

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 Number999520000002JJ Basic UDI-DI 07899995272355UDI-DIDate18 Aug 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  • Withdrawn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
Implant Strong Sw Plus | Implant Unitite | Implant Epikut Plus
Model / Reference
DENTAL IMPLANTS WITH HYDROXYAPATITE, SWHE 4511N
Primary DI / UDI-DI
07899995272355
Basic UDI-DI
999520000002JJ
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
BR-MF-000019848
Authorised representative
Biohorizons Camlog Portugal, Unipessoal, Lda. PT-AR-000052515

Other devices from S.I.N. Implant System Ltda.

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Properties

  • Sterile
  • Implantable
  • Sutures

Other properties (11)

  • 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