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Bloom System

by Sword Health S.A.

Ref Bloom SystemModel BS01

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5065013876BSBU Basic UDI-DI 15065013876037UDI-DIDate12 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
BS01, Bloom System
Primary DI / UDI-DI
15065013876037
Basic UDI-DI
5065013876BSBU
EMDN Code
U070399 Pelvic floor rehabilitation devices - other
Device Class
Class IIb
Medical Purpose
The Bloom System is designed for use exclusively with the Sword Bloom medical device software.

Manufacturer details

EUDAMED SRN
PT-PR-000046214

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Properties

Other properties (1)

  • Sterile: No