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Pulsar II AWI

by Apex (Suzhou) Medical Products Company 13 variants

Ref 209-00-47

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-16972130470316 Basic UDI-DI 16972130470316UDI-DIDate3 Jan 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  • Withdrawn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

Device Name
Disposable Irrigation Tip
Model / Reference
209-00-47
Primary DI / UDI-DI
16972130470316
Basic UDI-DI
B-16972130470316
EMDN Code
A0380 Tubular devices - accessories
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000031975
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Apex (Suzhou) Medical Products Company

See all devices from Apex (Suzhou) Medical Products Company →

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