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Sword Bloom

by Sword Health S.A.

Ref Sword BloomModel Version 8

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5065013876SBCD Basic UDI-DI 05065013876078UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05065013876078 UDI-DI Date2 Jun 2026ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Pelvic floor muscle exerciser
Model / Reference
Version 8 EUDAMED
Sword Bloom EUDAMED
8 GUDID
Primary DI / UDI-DI
05065013876078
Basic UDI-DI
5065013876SBCD
FDA Product Code
KXQ
EMDN Code
U070399 Pelvic floor rehabilitation devices - other
GMDN Term
Pelvic floor muscle exerciser
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
884.5960
Special Device Type
Software
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Version 8
Sword Bloom
GUDID
8
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
PT-MF-000039126

Other devices from Sword Health, S.A.

See all devices from Sword Health, S.A. →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No