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ISE Buffer Solution

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0801087

EMDN W01019001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0800877B Basic UDI-DIDate13 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
CH0801087
Primary DI / UDI-DI
06950617450955
Basic UDI-DI
69506174CH0800877B
Direct Marketing DI
06950617450955
EMDN Code
W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 06950617450955|69506174CH0800877B 61 fields · synced 25 Oct 2026