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Digital Dental X-ray Imaging device

by POINTIMPLANT Co., Ltd. 5 variants

Model Point 800S HD 3D Plus

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800011200107 Basic UDI-DI 08800011200107UDI-DIDate3 Dec 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  • Withdrawn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

Model / Reference
Point 800S HD 3D Plus
Primary DI / UDI-DI
08800011200107
Basic UDI-DI
B-08800011200107
EMDN Code
Z1103030102 Equipment for extraoral dental radiology, digital
Device Class
Class IIb
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
KR-MF-000031947
Authorised representative
Advena Limited MT-AR-000000234

Other devices from POINTIMPLANT Co., Ltd

Properties

  • Measuring Function

Other properties (10)

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