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Silverfox

by Silverfox Corporation Limited 17 variants

Ref 8000C-SRS0-E CONCORDModel 8000C

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 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/MDR Number6973134778000AB Basic UDI-DI 06973134776438UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Integral Dental Unit
Model / Reference
8000C, 8000C-SRS0-E CONCORD
Primary DI / UDI-DI
06973134776438
Basic UDI-DI
6973134778000AB
Direct Marketing DI
06973134776438
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000008252
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Silver Fox Corporation Limited

See all devices from Silver Fox Corporation 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