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IMP. ZYGOMATIC HE Ø4.5xØ3.85X62.5MM

by S.I.N. Implant System Ltda.

Ref IMZ 4162Model ZYGOMATIC DENTAL IMPLANTS WITHOUT 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number999520000003JL Basic UDI-DI 07899995209221UDI-DIDate17 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  • Withdrawn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 ZYGOMATIC - External Hexagon (HE) Connection
Model / Reference
ZYGOMATIC DENTAL IMPLANTS WITHOUT HYDROXYAPATITE, IMZ 4162
Primary DI / UDI-DI
07899995209221
Basic UDI-DI
999520000003JL
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