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Impression Transfer

by OsteoCare Implant System Limited 3 variants

Ref CO-ITO-4S, CO-ITO-5S, CO-ITC-5L, CO-ITC-4S, CO-ITO-3L, CO-ITC-3L, CO-ITC-3S, CO-ITO-3S, CO-ITC-5S, CO-ITO-5LModel Impression

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506091295Impression5W Basic UDI-DI Date30 Sep 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Impression, CO-ITO-4S, CO-ITO-5S, CO-ITC-5L, CO-ITC-4S, CO-ITO-3L, CO-ITC-3L, CO-ITC-3S, CO-ITO-3S, CO-ITC-5S, CO-ITO-5L
Primary DI / UDI-DI
50609129521684, 50609129522056, 50609129521752, 50609129521448, 50609129521134, 50609129520908, 50609129521066, 50609129521202, 50609129521820, 50609129521998
Basic UDI-DI
506091295Impression5W
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000016843
Authorised representative
OsteoCare Implant System Ireland Limited IE-AR-000009841

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Other devices from OsteoCare Implant System Limited

See all devices from OsteoCare Implant System Limited →

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