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Shun Pivot®

by Shunmei Medical Co., Ltd China EUDAMED

Ref 610412

EMDN F900201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06956014404126 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hemodialysis Catheter Kits
Model / Reference
610412
Primary DI / UDI-DI
06956014404126
Basic UDI-DI
B-06956014404126
EMDN Code
F900201 Temporary hemodialysis catheters and kits
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000001160
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shunmei Medical Co., Ltd

See all devices from Shunmei Medical Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 1b20e31f-60cc-4663-90a2-2ee169c2cf1a 61 fields · synced 22 Oct 2026