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Disposable Tips

by Yantai Addcare Bio-Tech Co., Ltd. China EUDAMED

Ref NOModel 800μL EMDN Z1399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360915500KX Basic UDI-DIDate22 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Disposable Tips
Model / Reference
800μL, NO
Primary DI / UDI-DI
06973609155003
Basic UDI-DI
697360915500KX
EMDN Code
Z1399 Non-specific consumables for diagnostic instruments - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000018409
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Yantai Addcare Bio-Tech Co., Ltd.

See all devices from Yantai Addcare Bio-Tech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 5410ead0-2012-4d13-8bce-8597f6674af1 61 fields · synced 22 Oct 2026