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Bioserenity Cloud

by Bioserenity Medical Devices Group United States EUDAMED

Ref 1012-21001-UN EMDN Z12040182

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number361522BiosCloudV09X Basic UDI-DIDate22 Dec 2025RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
1012-21001-UN
Primary DI / UDI-DI
03615220004362, 03615220004379
Basic UDI-DI
361522BiosCloudV09X
Direct Marketing DI
03615220004362
03615220004379
EMDN Code
Z12040182 General medicine diagnosis and monitoring instruments - software accessories
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000039391

Other devices from Bioserenity Medical Devices Group

See all devices from Bioserenity Medical Devices Group →

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 (2)

  • EUDAMED 6f25b0f4-1052-49c3-b07a-0c9ef2ed3fe0 61 fields · synced 25 Oct 2026
  • EUDAMED 03615220004379|361522BIOSCLOUDV09X 61 fields · synced 18 Jun 2026