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DANA Auto Setter

by SOOIL Development Co., Ltd. 2 variants

Ref SP-393Model DANA Auto Setter 4.0

Active European Union

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/MDD NumberB-08809220584978 Basic UDI-DI 08809220584978UDI-DIDate19 Jun 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
DANA Auto Setter
Model / Reference
DANA Auto Setter 4.0, SP-393
Primary DI / UDI-DI
08809220584978
Basic UDI-DI
B-08809220584978
EMDN Code
V0380 Devices with measuring functions - accessories
Device Class
Class IIb
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
KR-MF-000008627
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sooil Development Co., Ltd.

See all devices from Sooil Development Co., Ltd. →

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No