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Imidazole Buffered Saline

by SysCan BioTech (Suzhou) Co., Ltd. China EUDAMED

Ref TOP-IBS-15, STA-IBS-15, CM-IBS-15, Imidazole Buffered Saline, CS-IBS-15Model Ci-IBS-15 EMDN W0104010805

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697449025IBS003HF Basic UDI-DIDate22 Mar 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Ci-IBS-15, TOP-IBS-15, STA-IBS-15, CM-IBS-15, Imidazole Buffered Saline, CS-IBS-15
Primary DI / UDI-DI
06974490251072, 06974490251102, 06974490250150, 06974490251034, 06974490250143, 06974490251065, 06974490251058, 06974490251096, 06974490251089
Basic UDI-DI
697449025IBS003HF
Direct Marketing DI
06974490251072
06974490251102
06974490250150
06974490251034
06974490251065
06974490251058
06974490251096
06974490251089
EMDN Code
W0104010805 Buffers
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000040462
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from SysCan BioTech (Suzhou) Co., Ltd

See all devices from SysCan BioTech (Suzhou) 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 (9)

  • EUDAMED dd553348-c15d-4752-a721-844d1b47dbb1 61 fields · synced 22 Oct 2026
  • EUDAMED 06974490251102|697449025IBS003HF 61 fields · synced 17 May 2026
  • EUDAMED 06974490250150|697449025IBS003HF 61 fields · synced 17 May 2026
  • EUDAMED 06974490251034|697449025IBS003HF 61 fields · synced 17 May 2026
  • EUDAMED 06974490250143|697449025IBS003HF 61 fields · synced 18 May 2026
  • EUDAMED 06974490251065|697449025IBS003HF 61 fields · synced 18 May 2026
  • EUDAMED 06974490251058|697449025IBS003HF 61 fields · synced 19 May 2026
  • EUDAMED 06974490251096|697449025IBS003HF 61 fields · synced 19 May 2026
  • EUDAMED 06974490251089|697449025IBS003HF 61 fields · synced 19 May 2026