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Safersonic Single

by Safersonic Medizinprodukte Handelsges.m.b.H 10 variants

Ref SAF.612.18030.SEC

Active European Union

CE MDR CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-09120095070359 Basic UDI-DI 09120095070359UDI-DIDate20 Oct 2026RegisteredStatusActive
European UnionCE/MDD NumberB-09120095070359 Basic UDI-DI 09120095070359UDI-DIDate20 Oct 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Safersonic Sterile Transducer Cover with Adhesive Area
Model / Reference
SAF.612.18030.SEC
Primary DI / UDI-DI
09120095070359
Basic UDI-DI
B-09120095070359, 912009507STCOV-1LJ
EMDN Code
Z11049085 Various ultrasound instruments - consumables
Device Class
Class IIa
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
AT-MF-000020785

Other devices from Safersonic Medizinprodukte Handelsges.m.b.H

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Properties

  • Sterile

Other properties (12)

  • 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