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Single use sleeve Primescan Box 6890771

by SIRONA Dental Systems GmbH EUDAMEDGUDID

Active European Union

Ref 6890771

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number+E27668907710 UDI-DIDate22 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E276Sleeve10LZ Basic UDI-DIDate21 Sep 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Single use sleeve Primescan Box
Generic Name
Intraoral optical scanning system
Model / Reference
6890771
Primary DI / UDI-DI
+E27668907710 EUDAMED
E27668907712 GUDID
Basic UDI-DI
++E276Sleeve10LZ
FDA Product Code
NOF
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
GMDN Term
Intraoral optical scanning system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3661
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27668907710
GUDID
E27668907712
Device ClassEUDAMED
Class I
GUDID
Class II

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No