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BIOpH+ Medical foot bath

by Biocool AB

Ref 1000008

Active European Union

CE MDR

Valid until

5 Oct 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number739205910BPPFCCA Basic UDI-DI 07392059101726UDI-DIDate24 May 2024RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
BIOpH+ Footcare
Model / Reference
1000008
Primary DI / UDI-DI
07392059101726
Basic UDI-DI
739205910BPPFCCA
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000012411

Other devices from Biocool AB

Properties

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