Skip to content

LiNA SeaStar

by LiNA Medical AG 5 variants

Ref 4000-R-SLModel 4000-R-SL, 4000-R-SS, 4000-R-VL, 4000-R-VS, 4000-R-VV;

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, self-declared

Class I: no certifier involved

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 Number57082651019-12B Basic UDI-DI 05708265017614UDI-DIDate4 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
4000-R-SL, 4000-R-SS, 4000-R-VL, 4000-R-VS, 4000-R-VV
Primary DI / UDI-DI
05708265017614
Basic UDI-DI
57082651019-12B
EMDN Code
Z12019099 Various instruments for general and multidisciplinary surgery - other
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
CH-MF-000046832
Authorised representative
LiNA Medical Polska Sp. z o.o. PL-AR-000039364

Other devices from LiNA Medical AG

See all devices from LiNA Medical AG →

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