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STANDARD™ Fixed volume dropper (300ul)

by HLB Life Science Co., LTD South Korea EUDAMED

Ref 11PRT10AModel STANDARD™ Fixed volume dropper EMDN W0501010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880989962SVD01Y9 Basic UDI-DIDate22 Apr 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  • Withdrawn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 25 Oct 2026

Device Name
STANDARD™ Fixed volume dropper
Model / Reference
STANDARD™ Fixed volume dropper, 11PRT10A
Primary DI / UDI-DI
08809899621875
Basic UDI-DI
880989962SVD01Y9
EMDN Code
W0501010299 Capillary blood collection devices - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000031817
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Hlb Lifescience Co., Ltd.

See all devices from Hlb Lifescience Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 4f314d87-4cfd-49b5-ac7e-33a41e38f2ec 61 fields · synced 25 Oct 2026