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Single use sleeve Primescan 2 Box

by Sirona Dental Systems GmbH

Ref 6855840

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number+E27668558402M UDI-DI Date20 Aug 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E276Sleeve03M4 Basic UDI-DI Date9 Apr 2025RegisteredStatusActive

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

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Single use sleeve Primescan 2 Box EUDAMED
Primescan 2 GUDID
Generic Name
Intraoral optical scanning system
Model / Ref / Catalog
6855840
Primary DI / UDI-DI
+E27668558402M EUDAMED
+E27668558402 EUDAMED
E27668558402 GUDID
Basic UDI-DI
++E276Sleeve03M4
FDA Product Code
NOF, NTK, NBL
EMDN Code
Q010280 Prosthetic dentistry devices - accessories
GMDN Term
Intraoral optical scanning system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3661, 872.1745
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27668558402M
+E27668558402
GUDID
E27668558402
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000000029

Other devices from SIRONA Dental Systems GmbH

See all devices from SIRONA Dental Systems GmbH →

Properties

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

Other properties (20)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No