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Screw Lab. Hi 3.0 F/ Transfer. Tray Op.

by S.I.N. Implant System Ltda.

Ref PTMAIH 30Model LABORATORY DEVICE - CLASS I

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, self-declared

Class I: no certifier involved

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 Number999520000048KA Basic UDI-DI 07899995247162UDI-DIDate13 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Screw Laboratory
Model / Reference
LABORATORY DEVICE - CLASS I, PTMAIH 30
Primary DI / UDI-DI
07899995247162
Basic UDI-DI
999520000048KA
EMDN Code
P010299 Odontological prostheses - other
Device Class
Class I
EU market of registration
Portugal

Manufacturer details

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

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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