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Spasy

by Seawon Meditech Co., Ltd. 59 variants

Ref SWM10

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809272564690 Basic UDI-DI 08809272564690UDI-DIDate14 Apr 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
SWM10
Primary DI / UDI-DI
08809272564690
Basic UDI-DI
B-08809272564690
EMDN Code
A019011 Intraosseous infusion and vertebroplasty infusion needles and kits
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000007442
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Intraosseous infusion kit

Other devices from Seawon Meditech Co., Ltd.

See all devices from Seawon Meditech Co., Ltd. →

Properties

  • Sterile

Other properties (10)

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