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aposan

by Shenzhen Fitconn Technology Co., ltd China EUDAMED

Ref CNB69008Model CNB69009, CNB69008, CNB69011, CNB69010, CNB69006, CNB69007, CNB69012, CNB69016, CNB69017, CNB69018, CNB69020, CNB69021, CNB69022, CNB69025, CNB69026, CNB69028, CNB69021S, CNB69025S, CDC100, CDC200, CDC200S, CDC300S, CDC500 EMDN R060101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06970470484157 Basic UDI-DIDate16 Apr 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06970470484157 Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI26/1008022 Supplemented

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    1 Jul 2026
    Expires
    16 Apr 2031
    Reason
    Other

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Compressor Nebulizer
Model / Reference
CNB69008, CNB69009, CNB69011, CNB69010, CNB69006, CNB69007, CNB69012, CNB69016, CNB69017, CNB69018, CNB69020, CNB69021, CNB69022, CNB69025, CNB69026, CNB69028, CNB69021S, CNB69025S, CDC100, CDC200, CDC200S, CDC300S, CDC500
Primary DI / UDI-DI
06970470484157, 06970470480081
Basic UDI-DI
B-06970470484157, B-06970470480081, 697047048CNBCDCHA
Direct Marketing DI
06970470484157
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000024538
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Fitconn Technology Co., ltd

See all devices from Shenzhen Fitconn Technology Co., ltd →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (3)

  • EUDAMED 7a305afe-66f4-4864-b7cb-f084be80d3de 61 fields · synced 22 Oct 2026
  • EUDAMED 06970470480081|B-06970470480081 61 fields · synced 19 May 2026
  • EUDAMED 06970470484157|697047048CNBCDCHA 61 fields · synced 23 Oct 2026