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Disposable Tips

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

Active European Union

Ref E1, NOModel 1000 μL, 800μL（Filter）

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360915499M7 Basic UDI-DIDate30 Dec 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Disposable Tips
Model / Reference
1000 μL, E1, 800μL（Filter）, NO
Primary DI / UDI-DI
06973609154990, 06973609155027
Basic UDI-DI
697360915499M7, 697360915502L3
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

Show properties
  • 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